Please review the efficacy and safety of the Adalimumab and Adalimumab biosimilars.

Comment by InpharmD Researcher

Adalimumab biosimilars demonstrate efficacy comparable to reference adalimumab (Humira) across multiple immune-mediated inflammatory diseases, with consistent maintenance of disease control in both clinical trials and real-world settings. Safety profiles are also aligned, with similar rates of adverse events and serious infections, and no new safety signals identified. Immunogenicity findings are likewise comparable, with similar anti-drug antibody rates and no consistent impact on clinical outcomes. Evidence from switching studies further supports maintained effectiveness and safety after transitioning from reference adalimumab to biosimilars. Overall, available evidence supports the biosimilars as clinically equivalent alternatives with no meaningful differences in therapeutic performance.

Background

Across major evidence-based treatment guidelines covering various Food and Drug Administration (FDA)-approved indications, adalimumab is generally addressed at the tumor necrosis factor (TNF) inhibitor or biologic class level, with recommendations focused on biologic classes rather than individual branded products. Within these guidelines, reference adalimumab and biosimilars are not given separate recommendations or differentiated treatment pathways. [1], [2], [3], [4], [5], [6], [7], [8], [9], [10]

A 2025 comprehensive literature review synthesizing controlled trials and real-world evidence evaluated the efficacy, safety, and immunogenicity of SDZ-ADL (Sandoz adalimumab biosimilar, Hyrimoz®/GP2017) in biologic-naïve and biologic-experienced patients with immune-mediated inflammatory diseases. A structured literature search (up to July 2023) identified 15 peer-reviewed studies and 6 congress abstracts for inclusion (see Table 3), encompassing 923 patients from randomized controlled trials (RCTs) and over 2800 patients from observational cohorts and registries. Across pivotal phase III trials in plaque psoriasis (ADACCESS), rheumatoid arthritis (ADMYRA), and axial spondyloarthritis (SURPASS), SDZ-ADL demonstrated comparable efficacy to reference adalimumab across primary endpoints (e.g., Psoriasis Area and Severity Index [PASI] 75, Disease Activity Score-28 for Rheumatoid Arthritis with CRP [DAS28-CRP], radiographic progression) with no clinically meaningful differences in outcomes, including after single or multiple treatment switches. Similar findings were consistently observed across real-world cohorts in dermatologic, rheumatologic, and gastrointestinal diseases, where initiation or switching to SDZ-ADL maintained disease control and quality-of-life improvements comparable to reference adalimumab, with high treatment retention rates and low discontinuation frequencies. [11]

Across all evidence sources, SDZ-ADL showed a safety and immunogenicity profile comparable to reference adalimumab, with similar rates of adverse events, serious adverse events, and treatment-emergent infections, and no new safety signals identified after switching or prolonged exposure. Anti-drug antibody formation was generally similar between SDZ-ADL and reference adalimumab in clinical trials, with no consistent impact on efficacy or safety, including after multiple switches. Real-world evidence further supported stable safety outcomes, low switch-back rates, and sustained effectiveness across immune-mediated inflammatory diseases, although heterogeneity in study design and outcomes limits direct cross-study comparisons. Overall, the evidence consistently supports biosimilarity in clinical performance, with SDZ-ADL demonstrating maintained effectiveness, predictable safety, and comparable immunogenicity to reference adalimumab across both controlled and routine clinical practice settings. [11]

In a 2023 systematic review and meta-analysis evaluating the efficacy and safety of adalimumab biosimilars for moderate-to-severe plaque psoriasis, pooled data from 8 RCTs including 2,589 patients demonstrated that biosimilars were clinically equivalent to reference adalimumab across all key efficacy endpoints. After 16 weeks of treatment, there were no statistically significant differences between biosimilars and the originator drug in PASI 50, PASI 75, PASI 90, or PASI 100 response rates (all p > 0.05), with relative risks (RR) consistently close to unity (e.g., PASI 75 RR 0.99; 95% confidence interval [CI] 0.94 to 1.04). Longer-term data up to 24, 32, and 48-51 weeks similarly showed sustained and comparable response rates, with both groups maintaining high PASI 75 responses (generally 90-97% across studies) and no meaningful differences in efficacy over time. Safety outcomes were also comparable between biosimilars and reference adalimumab. Across 16 to 51 weeks of follow-up, there were no significant differences in serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), infections, nasopharyngitis, adverse events of special interest (AESIs), or discontinuations due to adverse events (all p > 0.05). Pooled analyses confirmed similar estimates for SAEs (RR 0.73; 95% CI 0.36 to 1.47), TEAEs (RR 1.03; 95% CI 0.93 to 1.14), and AESIs (RR 0.99; 95% CI 0.70 to 1.41), with no heterogeneity or emerging safety signals identified. Overall, the findings consistently support that adalimumab biosimilars provide equivalent efficacy and safety to the reference product in psoriasis, reinforcing their role as clinically comparable and cost-effective therapeutic alternatives. [12]

A 2025 systematic review and meta-analysis evaluated the efficacy, safety, and immunogenicity of biosimilars versus reference biologics in ankylosing spondylitis, including adalimumab, etanercept, and infliximab. Six head-to-head RCTs comprising 2,107 patients were included. Overall, biosimilars demonstrated comparable efficacy to originator biologics, with no significant differences in key clinical response measures such as ASAS20 (RR 1.01; 95% CI 0.96 to 1.07) or ASAS40 (RR 1.00; 95% CI 0.94 yo 1.05). Secondary efficacy outcomes, disease activity indices, safety outcomes (including overall adverse events), and immunogenicity measures (such as anti-drug antibody formation) were also similar between groups. Sensitivity and subgroup analyses confirmed the consistency and robustness of these findings, supporting the conclusion that biosimilars are clinically equivalent to reference biologics in ankylosing spondylitis. Unfortunately, only the abstract of the analysis was available for scrutiny, which limits a comprehensive assessment of the findings and makes it unclear whether results were specifically stratified for adalimumab. [13]

Additional reviews and meta-analyses consistently support the clinical biosimilarity of adalimumab biosimilars to reference adalimumab in rheumatoid arthritis (RA). Across the evidence, adalimumab biosimilars (including agents such as ABP 501, BI 695501, SB5, GP2017, MSB11022, FKB327, and PF-06410293) demonstrated highly similar efficacy, safety, pharmacokinetics, and immunogenicity compared with originator adalimumab in RA and other immune-mediated inflammatory diseases. These reviews consistently report that switching studies show no clinically meaningful differences in efficacy outcomes, trough serum drug concentrations, safety profiles, or anti-drug antibody formation after transitioning from reference adalimumab to biosimilars, with regulatory equivalence criteria met across all major agents. Additionally, one meta-analysis of 25 head-to-head randomized controlled trials involving 10,642 patients with moderate-to-severe RA (covering adalimumab, infliximab, and etanercept biosimilars) confirmed therapeutic equivalence between biosimilars and reference biologics. Pooled estimates showed no significant differences in efficacy outcomes, including ACR20 response (risk ratio 1.01; 95% credible interval 0.98 to 1.04) and HAQ-DI improvement (standardized mean difference -0.04; 95% credible interval -0.11 to 0.02), with safety and immunogenicity outcomes also comparable within prespecified equivalence margins. Trial sequential analyses further supported that equivalence for key outcomes was established and remained stable over time. Overall, the evidence consistently demonstrates that adalimumab biosimilars provide equivalent efficacy, safety, and immunogenicity compared with reference adalimumab in RA, with no clinically meaningful differences identified across trials or pooled analyses. [14], [15], [16], [17]

Literature Review

A search of the published medical literature revealed 3 studies investigating the researchable question:

Please review the efficacy and safety of the Adalimumab and Adalimumab biosimilars.

Level of evidence

B - One high-quality study or multiple studies with limitations Read more→

Please see Tables 1-3 for your response.

Humira and Biosimilars Chart
Proper Name	Adalimumab	Adalimumab-adbm	Adalimumab-afzb	Adalimumab-ryvk	Adalimumab-atto	Adalimumab-adaz	Adalimumab-bwwd	Adalimumab-fkjp	Adalimumab-aqvh	Adalimumab-aacf	Adalimumab-aaty
Other Name	D2E7	BI 695501	PF-06410293	AVT02	ABP 501	GP2017	SB5	FKB327	CHS-1420	MSB11022	CT-P17
Brand (Manufacturer)	Humira® (AbbVie)	Cyltezo® (Boehringer Ingelheim)	Abrilada® (Pfizer)	Simlandi® (Alvotech)	Amjevita™ (Amgen)	Hyrimoz® (Sandoz)	Hadlima™ (Samsung Bioepis)	Hulio® (Biocon Biologics)	Yusimry™ (Coherus BioSciences)	Idacio® (Fresenius Kabi)	Yuflyma® (Celltrion)
Rated Interchangeable with Reference Agent?	(Reference agent)	Yes	Yes	Yes	No	No	No	No	No	No	No
Strength & formulations:
Autoinjector:
40MG/0.8ML	☑ (contains citrate; needle cover contains latex)	☑ (needle cover contains latex)	☑	-	☑	☑	☑ (contains citrate)	☑	☑	☑	-
40MG/0.4ML	☑	-	-	☑	☑	☑	☑ (contains citrate)	-	-	-	☑
80MG/0.8ML	☑	-	-	-	☑	☑	-	-	-	-	☑
Pre-filled syringe:
10MG/0.1ML	☑	-	-	-	-	☑	-	-	-	-	-
10MG/0.2ML	☑ (contains citrate; needle cover contains latex)	☑ (needle cover contains latex)	☑	-	☑	☑	-	-	-	-	-
20MG/0.2ML	☑	-	-	-	☑	☑	-	-	-	-	☑
20MG/0.4ML	☑ (contains citrate; needle cover contains latex)	☑ (needle cover contains latex)	☑	-	☑	☑	-	☑	-	-	-
40MG/0.4ML	☑	-	-	-	☑	☑	☑	-	-	-	☑
40MG/0.8ML	☑ (contains citrate; needle cover contains latex)	☑ (needle cover contains latex)	☑	-	☑	☑	☑ (contains citrate)	☑	☑	☑	-
80MG/0.8ML	☑	-	-	-	☑	☑	-	-	-	-	☑
Single-dose vial:
40MG/0.8ML	☑	-	☑	-	-	-	☑ (contains citrate)	-	-	☑	-
Formulary Status
FDA Approval Date	12/31/2002	08/25/2017	11/15/2019	02/23/2024	09/23/2016	10/30/2018	07/23/2019	07/06/2020	12/17/2021	12/13/2022	05/23/2023
FDA approved indications:
Rheumatoid arthritis (moderately to severely active) (Adults): to reduce signs and symptoms, induce major clinical response, inhibit progression of structural damage, and improve physical function: used ± non-biologic DMARDs (ex: MTX)	☑	☑	☑	☑	☑	☑	☑	☑	☑	☑	☑
Juvenile Idiopathic Arthritis (moderately to severely active)(pts ≥2 yo): to reduce signs & symptoms: used ± MTX	☑	☑	☑	☑	☑	☑	☑	☑	☑	☑	☑
Psoriatic Arthritis (active) (Adults): to reduce signs & symptoms, inhibit progression of structural damage, and improve physical function: used ± non-biologic DMARDs	☑	☑	☑	☑	☑	☑	☑	☑	☑	☑	☑
Ankylosing Spondylitis (active)(Adults): to reduce signs & symptoms	☑	☑	☑	☑	☑	☑	☑	☑	☑	☑	☑
Crohn’s Disease (moderately to severely active)(pts ≥6 yo): as treatment	☑	☑	☑	☑	☑	☑	☑	☑	☑	☑	☑
Ulcerative Colitis (moderately to severely active)(Adults): as treatment (limitation of use: effectiveness not established in pts intolerant of- or who have lost response to TNF-blockers)	☑	☑	☑	☑	☑	☑	☑	☑	☑	☑	☑
Ulcerative Colitis (moderately to severely active)(pts ≥5 yo): as treatment (limitation of use: effectiveness not established in pts intolerant of- or who have lost response to TNF-blockers)	☑	-	-	-	-	-	-	-	-	-	-
Plaque Psoriasis (moderate to severe; chronic)(Adults): in candidates for systemic therapy or phototherapy, when other systemic therapies are medically less appropriate, with close monitoring: as treatment	☑	☑	☑	☑	☑	☑	☑	☑	☑	☑	☑
Hidradenitis Suppurativa (moderate to severe) (Adults): as treatment	☑	☑	☑	☑	☑	-	☑	☑	☑	-	☑
Hidradenitis Suppurativa (moderate to severe) (pts ≥12 yo): as treatment	☑	-	-	-	-	-	-	-	-	-	-
Uveitis (non-infectious: intermediate, posterior, and panuveitis) (Adults): as treatment	☑	☑	☑	☑	☑	-	☑	☑	☑	-	☑
Uveitis (non-infectious: intermediate, posterior, and panuveitis) (pts ≥2 yo): as treatment	☑	-	-	-	-	-	-	-	-	-	-

References:
[1] [1] Humira (adalimumab, subcutaneous, injection, solution, kit). Prescribing information. AbbVie; 2025.
[2] [2] Cyltezo (adalimumab-adbm, subcutaneous, injection, solution). Prescribing information. Boehringer Ingelheim; 2025.
[3] [3] Abrilada (adalimumab-afzb, subcutaneous, injection, solution). Prescribing information. Pfizer; 2025.
[4] [4] Simlandi (adalimumab-ryvk, subcutaneous, injection, solution). Prescribing information. Alvotech; 2025.
[5] [5] Amjevita (adalimumab-atto, subcutaneous, injection, solution). Prescribing information. Amgen; 2025.
[6] [6] Hyrimoz (adalimumab-adaz, subcutaneous, injection, solution). Prescribing information. Sandoz; 2025.
[7] [7] Hadlima (adalimumab-bwwd, subcutaneous, injection, solution). Prescribing information. Organon; 2025.
[8] [8] Hulio (adalimumab-fkjp, subcutaneous, injection, solution). Prescribing information. Biocon; 2025.
[9] [9] Yusimry (adalimumab-aqvh, subcutaneous, injection, solution). Prescribing information. Coherus; 2025.
[10] [10] Idacio (adalimumab-aacf, subcutaneous, injection, solution). Prescribing information. Fresenius Kabi; 2025.
[11] [11] Yuflyma (adalimumab-aaty, subcutaneous, injection, solution). Prescribing information. Celltrion; 2025.

Humira and Biosimilars Dosing Chart

Brand Name

Dosing

Humira

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis:

Adults: 40 mg administered every other week
Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week.

Juvenile Idiopathic Arthritis or Pediatric Patients with Uveitis (2 Years of Age and older):

10 kg (22 lbs) to less than 15 kg (33 lbs): 10 mg every other week
15 kg (33 lbs) to less than 30 kg (66 lbs): 20 mg every other week
30 kg (66 lbs) and greater: 40 mg every other week

Crohn’s Disease:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29
Pediatric patients 6 years of age and older:

Pediatric Weight	Recommended Dosage
	Days 1 through 15	Starting on Day 29
17 kg (37 lbs) to less than 40 kg (88 lbs)	Day 1: 80 mg Day 15: 40 mg	20 mg every other week
40 kg (88 lbs) and greater	Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg	40 mg every other week

Ulcerative Colitis:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29
Pediatric:

Pediatric Weight	Recommended Dosage
	Days 1 through 15	Starting on Day 29*
20 kg (44 lbs) to less than 40 kg (88 lbs)	Day 1: 80 mg Day 8: 40 mg Day 15: 40 mg	40 mg every other week or 20 mg every week
40 kg (88 lbs) and greater	Day 1: 160 mg (single dose or split over two consecutive days) Day 8: 80 mg Day 15: 80 mg	80 mg every other week or 40 mg every week
* Continue the recommended pediatric dosage in patients who turn 18 years of age and who are well-controlled on their HUMIRA regimen.

Plaque Psoriasis or Adults with Uveitis: Initial dose of 80 mg, then 40 mg given every other week starting one week after the initial dose

Hidradenitis Suppurativa:

Adult: Initial dose of 160 mg (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg weekly or 80 mg every other week dosing on Day 29
Pediatric patients 12 years of age and older:

Body Weight of Pediatric Patients (12 years of age and older)	Recommended Dosage
30 kg (66 lbs) to less than 60 kg (132 lbs)	Day 1: 80 mg Day 8 and subsequent doses: 40 mg every other week
60 kg (132 lbs) and greater	Day 1: 160 mg (given in one day or split over two consecutive days); Day 15: 80 mg Day 29 and subsequent doses: 40 mg every week or 80 mg every other week

Cyltezo

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis:

Adults: 40 mg administered every other week
Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week.

Juvenile Idiopathic Arthritis or Pediatric Patients with Uveitis (2 Years of Age and older):

10 kg (22 lbs) to less than 15 kg (33 lbs): 10 mg every other week
15 kg (33 lbs) to less than 30 kg (66 lbs): 20 mg every other week
30 kg (66 lbs) and greater: 40 mg every other week

Crohn’s Disease:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29
Pediatric patients 6 years of age and older:

Pediatric Weight	Recommended Dosage
	Days 1 through 15	Starting on Day 29
17 kg (37 lbs) to less than 40 kg (88 lbs)	Day 1: 80 mg Day 15: 40 mg	20 mg every other week
40 kg (88 lbs) and greater	Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg	40 mg every other week

Ulcerative Colitis:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29

Plaque Psoriasis or Adults with Uveitis: Initial dose of 80 mg, then 40 mg given every other week starting one week after the initial dose

Hidradenitis Suppurativa:

Adult: Initial dose of 160 mg (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg weekly or 80 mg every other week dosing on Day 29
Pediatric patients 12 years of age and older:

Body Weight of Pediatric Patients (12 years of age and older)	Recommended Dosage
30 kg (66 lbs) to less than 60 kg (132 lbs)	Day 1: 80 mg Day 8 and subsequent doses: 40 mg every other week
60 kg (132 lbs) and greater	Day 1: 160 mg (given in one day or split over two consecutive days); Day 15: 80 mg Day 29 and subsequent doses: 40 mg every week or 80 mg every other week

Abrilada

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis:

Adults: 40 mg administered every other week
Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week.

Juvenile Idiopathic Arthritis (2 Years of Age and older):

10 kg (22 lbs) to less than 15 kg (33 lbs): 10 mg every other week
15 kg (33 lbs) to less than 30 kg (66 lbs): 20 mg every other week
30 kg (66 lbs) and greater: 40 mg every other week

Crohn's Disease:

Adults: 160 mg on Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; and 40 mg every other week starting on Day 29.
Pediatric Patients 6 Years of Age and Older:

Pediatric Weight	Recommended Dosage
	Days 1 and 15	Starting on Day 29
17 kg (37 lbs) to less than 40 kg (88 lbs)	Day 1: 80 mg Day 15: 40 mg	20 mg every other week
40 kg (88 lbs) and greater	Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg	40 mg every other week

Ulcerative Colitis:

Adults: 160 mg on Day 1 (given in one day or split over two consecutive days), 80 mg on Day 15 and 40 mg every other week starting on Day 29. Discontinue in patients without evidence of clinical remission by eight weeks (Day 57).

Plaque Psoriasis or Adult Uveitis:

Adults: 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose.

Hidradenitis Suppurativa:

Adults:
Day 1: 160 mg (given in one day or split over two consecutive days).
Day 15: 80 mg.
Day 29 and subsequent doses: 40 mg every week or 80 mg every other week.

Simlandi

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis:

Adults: 40 mg administered every other week
Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week.

Juvenile Idiopathic Arthritis or Pediatric Patients with Uveitis (2 Years of Age and older)*:

15 kg (33 lbs) to less than 30 kg (66 lbs): 20 mg every other week
30 kg (66 lbs) and greater: 40 mg every other week

*There is no dosage form for SIMLANDI that allows weight-based dosing for pediatric patients below 15 kg.

Crohn’s Disease:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29
Pediatric patients 6 years of age and older:

Pediatric Weight	Recommended Dosage
	Days 1 through 15	Starting on Day 29
17 kg (37 lbs) to less than 40 kg (88 lbs)	Day 1: 80 mg Day 15: 40 mg	20 mg every other week
40 kg (88 lbs) and greater	Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg	40 mg every other week

Ulcerative Colitis:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29

Plaque Psoriasis or Adults with Uveitis: Initial dose of 80 mg, then 40 mg given every other week starting one week after the initial dose

Hidradenitis Suppurativa:

Adult: Initial dose of 160 mg (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg weekly or 80 mg every other week dosing on Day 29
Pediatric patients 12 years of age and older:

Body Weight of Pediatric Patients (12 years of age and older)	Recommended Dosage
30 kg (66 lbs) to less than 60 kg (132 lbs)	Day 1: 80 mg Day 8 and subsequent doses: 40 mg every other week
60 kg (132 lbs) and greater	Day 1: 160 mg (given in one day or split over two consecutive days); Day 15: 80 mg Day 29 and subsequent doses: 40 mg every week or 80 mg every other week

Amjevita

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis:

Adults: 40 mg administered every other week
Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week.

Juvenile Idiopathic Arthritis or Pediatric Patients with Uveitis (2 Years of Age and older):

10 kg (22 lbs) to less than 15 kg (33 lbs): 10 mg every other week
15 kg (33 lbs) to less than 30 kg (66 lbs): 20 mg every other week
30 kg (66 lbs) and greater: 40 mg every other week

Crohn’s Disease:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29
Pediatric patients 6 years of age and older:

Pediatric Weight	Recommended Dosage
	Days 1 through 15	Starting on Day 29
17 kg (37 lbs) to less than 40 kg (88 lbs)	Day 1: 80 mg Day 15: 40 mg	20 mg every other week
40 kg (88 lbs) and greater	Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg	40 mg every other week

Ulcerative Colitis:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29

Plaque Psoriasis or Adults with Uveitis: Initial dose of 80 mg, then 40 mg given every other week starting one week after the initial dose

Hidradenitis Suppurativa:

Adult: Initial dose of 160 mg (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg weekly or 80 mg every other week dosing on Day 29
Pediatric patients 12 years of age and older:

Body Weight of Pediatric Patients (12 years of age and older)	Recommended Dosage
30 kg (66 lbs) to less than 60 kg (132 lbs)	Day 1: 80 mg Day 8 and subsequent doses: 40 mg every other week
60 kg (132 lbs) and greater	Day 1: 160 mg (given in one day or split over two consecutive days); Day 15: 80 mg Day 29 and subsequent doses: 40 mg every week or 80 mg every other week

Hyrimoz

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis:

Adults: 40 mg administered every other week
Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week.

Juvenile Idiopathic Arthritis or Pediatric Patients with Uveitis (2 Years of Age and older):

10 kg (22 lbs) to less than 15 kg (33 lbs): 10 mg every other week
15 kg (33 lbs) to less than 30 kg (66 lbs): 20 mg every other week
30 kg (66 lbs) and greater: 40 mg every other week

Crohn’s Disease:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29
Pediatric patients 6 years of age and older:

Pediatric Weight	Recommended Dosage
	Days 1 through 15	Starting on Day 29
17 kg (37 lbs) to less than 40 kg (88 lbs)	Day 1: 80 mg Day 15: 40 mg	20 mg every other week
40 kg (88 lbs) and greater	Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg	40 mg every other week

Ulcerative Colitis:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29

Plaque Psoriasis or Adults with Uveitis: Initial dose of 80 mg, then 40 mg given every other week starting one week after the initial dose

Hidradenitis Suppurativa:

Adult: Initial dose of 160 mg (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg weekly or 80 mg every other week dosing on Day 29
Pediatric patients 12 years of age and older:

Body Weight of Pediatric Patients (12 years of age and older)	Recommended Dosage
30 kg (66 lbs) to less than 60 kg (132 lbs)	Day 1: 80 mg Day 8 and subsequent doses: 40 mg every other week
60 kg (132 lbs) and greater	Day 1: 160 mg (given in one day or split over two consecutive days); Day 15: 80 mg Day 29 and subsequent doses: 40 mg every week or 80 mg every other week

Hadlima

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis:

Adults: 40 mg administered every other week
Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week.

Juvenile Idiopathic Arthritis (2 Years of Age and older):

10 kg (22 lbs) to less than 15 kg (33 lbs): 10 mg every other week
15 kg (33 lbs) to less than 30 kg (66 lbs): 20 mg every other week
30 kg (66 lbs) and greater: 40 mg every other week

Crohn’s Disease:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29
Pediatric patients 6 years of age and older:

Pediatric Weight	Recommended Dosage
	Days 1 through 15	Starting on Day 29
17 kg (37 lbs) to less than 40 kg (88 lbs)	Day 1: 80 mg Day 15: 40 mg	20 mg every other week
40 kg (88 lbs) and greater	Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg	40 mg every other week

Ulcerative Colitis:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29

Plaque Psoriasis or Adults with Uveitis: Initial dose of 80 mg, then 40 mg given every other week starting one week after the initial dose

Hidradenitis Suppurativa:

Adult: Initial dose of 160 mg (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg weekly or 80 mg every other week dosing on Day 29

Hulio

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis:

Adults: 40 mg administered every other week
Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week.

Juvenile Idiopathic Arthritis (2 Years of Age and older)*:

15 kg (33 lbs) to less than 30 kg (66 lbs): 20 mg every other week
30 kg (66 lbs) and greater: 40 mg every other week

*There is no dosage form for HULIO that allows weight-based dosing for pediatric patients below 15 kg.

Crohn’s Disease:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29
Pediatric patients 6 years of age and older:

Pediatric Weight	Recommended Dosage
	Days 1 through 15	Starting on Day 29
17 kg (37 lbs) to less than 40 kg (88 lbs)	Day 1: 80 mg Day 15: 40 mg	20 mg every other week
40 kg (88 lbs) and greater	Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg	40 mg every other week

Ulcerative Colitis:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29

Plaque Psoriasis or Adults with Uveitis: Initial dose of 80 mg, then 40 mg given every other week starting one week after the initial dose

Hidradenitis Suppurativa:

Adult: Initial dose of 160 mg (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg weekly or 80 mg every other week dosing on Day 29

Yusimry

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis:

Adults: 40 mg administered every other week
Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week.

Juvenile Idiopathic Arthritis (2 Years of Age and older)*:

30 kg (66 lbs) and greater: 40 mg every other week

*There is no dosage form for YUSIMRY that allows weight-based dosing for pediatric patients below 30 kg. Adalimumab products have not been studied in patients with polyarticular JIA less than 2 years of age or in patients with a weight below 10 kg.

Crohn’s Disease:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29
Pediatric patients 6 years of age and older:

Pediatric Weight	Recommended Dosage
	Days 1 through 15	Starting on Day 29
40 kg (88 lbs) and greater	Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg	40 mg every other week

Ulcerative Colitis:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29

Plaque Psoriasis or Adults with Uveitis: Initial dose of 80 mg, then 40 mg given every other week starting one week after the initial dose

Hidradenitis Suppurativa:

Adult: Initial dose of 160 mg (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg weekly or 80 mg every other week dosing on Day 29

Idacio

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis:

Adults: 40 mg administered every other week
Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week.

Juvenile Idiopathic Arthritis (2 Years of Age and older):

10 kg (22 lbs) to less than 15 kg (33 lbs): 10 mg every other week
15 kg (33 lbs) to less than 30 kg (66 lbs): 20 mg every other week
30 kg (66 lbs) and greater: 40 mg every other week

Crohn’s Disease:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29
Pediatric patients 6 years of age and older:

Pediatric Weight	Recommended Dosage
	Days 1 through 15	Starting on Day 29
17 kg (37 lbs) to less than 40 kg (88 lbs)	Day 1: 80 mg Day 15: 40 mg	20 mg every other week
40 kg (88 lbs) and greater	Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg	40 mg every other week

Ulcerative Colitis:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29

Plaque Psoriasis or Adults with Uveitis: Initial dose of 80 mg, then 40 mg given every other week starting one week after the initial dose

Hidradenitis Suppurativa:

Adult: Initial dose of 160 mg (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg weekly or 80 mg every other week dosing on Day 29

Yuflyma

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis:

Adults: 40 mg administered every other week
Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week.

Juvenile Idiopathic Arthritis or Pediatric Patients with Uveitis (2 Years of Age and older):

10 kg (22 lbs) to less than 15 kg (33 lbs): 10 mg every other week
15 kg (33 lbs) to less than 30 kg (66 lbs): 20 mg every other week
30 kg (66 lbs) and greater: 40 mg every other week

Crohn’s Disease:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29
Pediatric patients 6 years of age and older:

Pediatric Weight	Recommended Dosage
	Days 1 through 15	Starting on Day 29
17 kg (37 lbs) to less than 40 kg (88 lbs)	Day 1: 80 mg Day 15: 40 mg	20 mg every other week
40 kg (88 lbs) and greater	Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg	40 mg every other week

Ulcerative Colitis:

Adult: 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg every other week starting Day 29

Plaque Psoriasis or Adults with Uveitis: Initial dose of 80 mg, then 40 mg given every other week starting one week after the initial dose

Hidradenitis Suppurativa:

Adult: Initial dose of 160 mg (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15); 40 mg weekly or 80 mg every other week dosing on Day 29
Pediatric patients 12 years of age and older:

Body Weight of Pediatric Patients (12 years of age and older)	Recommended Dosage
30 kg (66 lbs) to less than 60 kg (132 lbs)	Day 1: 80 mg Day 8 and subsequent doses: 40 mg every other week
60 kg (132 lbs) and greater	Day 1: 160 mg (given in one day or split over two consecutive days); Day 15: 80 mg Day 29 and subsequent doses: 40 mg every week or 80 mg every other week

Summary of clinical studies and real-world evidence of SDZ-ADL
No.	Author, year	Study design	Treatment of interest	Patient numbers by indication	Efficacy outcomes	Safety	Immunogenicity
Clinical studies
1	Blauvelt et al. 2018	Phase III, randomized, double-blinded	SDZ-ADL ref-ADL	SDZ-ADL: 231 PsO pts ref-ADL: 234 PsO pts	PASI 75 response at Wk 16, adjusted response rate, % ± SE SDZ-ADL: 66.8 ± 3.3 ref-ADL: 65.0 ± 3.4 Δ, % ± SE (95% CI): 1.8 ± 4.8 (− 7.5; 11.2) (equivalence margin of ± 18%) Percentage change from baseline to Wk 16 in PASI, LSM, % ± SE SDZ-ADL: − 60.7 ± 1.5 ref-ADL: − 61.5 ± 1.6 Δ, % ± SE (95% CI): 0.8 ± 2.0 (− 3.2; 4.8) (equivalence margin of ± 15%)	Pts with ≥ 1 AE up to Wk 17, % SDZ-ADL: 50.2 ref-ADL: 52.6 Pts with ≥ 1 AE between Wk 17–51, % Cont. SDZ-ADL: 52.4 Cont. ref-ADL: 55.9 Switched to SDZ-ADL: 46.0 Switched to ref-ADL: 57.0	Pts ADA-positive up to Wk 17, % SDZ-ADL: 36.8 ref-ADL: 34.1 Pts ADA-positive between Wk 17–51, % Cont. SDZ-ADL: 35.8 Cont. ref-ADL: 45.1 Switched to SDZ-ADL: 39.0 Switched to ref-ADL: 47.0
2	Blauvelt et al. 2021	Two phase III, randomized, double-blinded studies	SDZ-ADL ref-ADL	ADACCESS study SDZ-ADL: 231 PsO pts ref-ADL: 234 PsO pts ADMYRA study SDZ-ADL: 177 RA pts ref-ADL: 176 RA pts	ADACCESS study PRO assessments at Wk 17, mean (SD) DLQI: SDZ-ADL: 4.2 (5.7) ref-ADL: 3.9 (5.3) EQ-5D-5L: SDZ-ADL: 80.6 (17.6) ref-ADL: 80.9 (19.4) HAQ-DI: SDZ-ADL: 0.5 (0.6) ref-ADL: 0.5 (0.6) PRO assessments at Wk 51, mean (SD) DLQI: Cont. SDZ-ADL: 2.4 (4.1) Cont. ref-ADL: 2.3 (3.2) Switched to SDZ-ADL: 4.1 (5.3) Switched to ref-ADL: 3.1 (5.0) EQ-5D-5L: Cont. SDZ-ADL: 87.4 (10.2) Cont. ref-ADL: 88.3 (10.9) Switched to SDZ-ADL: 85.0 (16.5) Switched to ref-ADL: 85.5 (12.4) HAQ-DI: Cont. SDZ-ADL: 0.4 (0.5) Cont. ref-ADL: 0.4 (0.6) Switched to SDZ-ADL: 0.5 (0.8) Switched to ref-ADL: 0.7 (0.6) ADMYRA study PRO assessments at Wk 24, mean (SD) HAQ-DI: SDZ-ADL: 0.8 (0.6) ref-ADL: 0.9 (0.6) FACIT-Fatigue score: SDZ-ADL: 37.1 (9.2) ref-ADL: 38.1 (9.3) PRO assessments at Wk 48, mean (SD) HAQ-DI: SDZ-ADL: 0.9 (0.7) ref-ADL to SDZ-ADL switch: 0.8 (0.7) FACIT-Fatigue score: SDZ-ADL: 36.2 (9.8) ref-ADL to SDZ-ADL switch: 37.0 (9.7)	–	–
3	Wiland et al. 2020	Phase III, randomized, double-blinded	SDZ-ADL ref-ADL	SDZ-ADL: 177 RA pts ref-ADL: 176 RA pts	Change from baseline to Wk 12 in DAS28-CRP, LSM ± SE SDZ-ADL: − 2.16 ± 0.11 ref-ADL: − 2.18 ± 0.11 Δ (95% CI): 0.02 (− 0.24; 0.27) Time-averaged change from baseline to Wk 24 in DAS28‑CRP, LSM ± SE SDZ-ADL: − 1.85 ± 0.10 ref-ADL: − 1.93 ± 0.09 Δ (95% CI): 0.08 (− 0.11; 0.27) Change from baseline to Wk 48 in DAS28-CRP, mean ± SD SDZ-ADL: − 3.09 ± 1.09 ref-ADL/switched to SDZ-ADL: − 3.05 ± 1.27 ACR20/50/70 response rates at Wk 48, % SDZ-ADL: 86.1/66.7/45.4 ref-ADL/switched to SDZ-ADL: 88.1/64.3/43.7	Pts with ≥ 1 TEAE up to Wk 48, % SDZ-ADL: 70.6 ref-ADL/switched to SDZ-ADL: 68.8 Pts with ≥ 1 SAE up to Wk 48, % SDZ-ADL: 4.0 ref-ADL/switched to SDZ-ADL: 5.7	Pts ADA-positive up to Wk 48, % SDZ-ADL: 24.2% (72.5% of these patients were nADA-positive) Ref-ADL/switched to SDZ-ADL: 25.6% (79.1% of these patients were nADA-positive) Pts ADA-positive after switch at Wk 24 up to Wk 48, % SDZ-ADL: 24.0 (72.2% of these pts were nADA-positive) Ref-ADL/switched to SDZ-ADL: 26.3 (81.0% of these pts were nADA-positive)
4	Baraliakos et al. 2022	Phase III, randomized, open-label	SDZ-ADL Secukinumab	SDZ-ADL: 286 axSpA pts SEC (150 mg): 287 axSpA pts SEC (300 mg): 286 axSpA pts	Pts with no radiographic progression (mSASSS ≤ 0.5) at Wk 104, est. mean % (95% CI) SDZ-ADL: 65.1 (58.8; 71.5) SEC (150 mg): 66.6 (60.7; 72.5) SEC (300 mg): 66.8 (60.5; 73.1) Change from baseline to Wk 16 in MRI SIJ score, mean ± SE SDZ-ADL: –1.51 ± 0.14 SEC (150 mg): –1.22 ± 0.14 SEC (300 mg): –1.10 ± 0.14 Change from baseline to Wk 16 in MRI spine score, mean ± SE SDZ-ADL: –2.31 ± 0.15 SEC (150 mg): –1.43 ± 0.14 SEC (300 mg): –1.59 ± 0.15 Change from baseline to Wk 104 in mSASSS, LSM ± SE SDZ-ADL: 0.72 ± 0.18 SEC (150 mg): 0.54 ± 0.18 SEC (300 mg): 0.55 ± 0.18 Pts with no new syndesmophytes at Wk 104 (in pts with ≥ 1 syndesmophyte at baseline), % SDZ-ADL: 53.3 SEC (150 mg): 56.9 SEC (300 mg): 53.8	Pts with ≥ 1 AE, % SDZ-ADL: 84.2 SEC (150 mg): 79.7 SEC (300 mg): 81.8 Pts with ≥ 1 SAE, % SDZ-ADL: 11.2 SEC (150 mg): 14.0 SEC (300 mg): 10.2	–
5	von Richter et al. 2019	Phase I, randomized, double-blinded	SDZ-ADL ref-ADL	SDZ-ADL: 107 subjects ref-ADL: 211 subjects	GMR (90% CI) of SDZ-ADL/EU ref-ADL C_max: 1.05 (0.99 to 1.11) ng/ml AUC_0–inf: 1.04 (0.96 to 1.13) ng × h/ml GMR (90% CI) of SDZ-ADL/US ref-ADL C_max: 1.00 (0.94 to 1.06) ng/ml AUC_0–inf: 1.08 (1.00 to 1.18) ng × h/ml (prespecified PK similarity margin 0.80–1.25)	Subjects with ≥ 1 TEAE, % SDZ-ADL: 71.0 US ref-ADL: 68.6 EU ref-ADL: 70.8	SDZ-ADL ADA: 57.9% nADA: 54.2% US ref-ADL ADA: 69.5% nADA: 62.9% EU ref-ADL ADA: 69.8% nADA: 64.2%
6	von Richter et al. 2019	Two phase I, single-center, randomized, double-blinded studies	SDZ-ADL	197 subjects	GMR (90% CI) between two studies SDZ-ADL exposure parameters C_max: 0.95 (0.89 to 1.01) ng/ml AUC_0–last: 0.80 (0.72 to 0.90) ng × h/ml AUC_0–360 h: 0.92 (0.86 to 0.99) ng × h/ml AUC_0–inf: 0.80 (0.72 to 0.89) ng × h/ml	Subjects with ≥ 1 AE, % GP17-103 study: 45.6 GP17-104 study: 71.0	ADA-positive pts, % GP17-103 study: 71.1 GP17-104 study: 57.9
7	von Richter et al. 2023	Phase I, randomized, multicenter, double-blinded	SDZ-ADL (HCF vs. LCF)	SDZ-ADL-HCF: 162 subjects SDZ-ADL-LCF: 168 subjects	GMR (90% CI) of HCF vs. LCF C_max: 1.02 (0.95 to 1.10) ng/ml AUC_0–last: 1.04 (0.94 to 1.16) ng × h/ml AUC_0–360 h: 1.03 (0.96 to 1.11) ng × h/ml AUC_0–inf: 1.06 (0.98 to 1.15) ng × h/ml (prespecified PK similarity margin 0.80–1.25)	Subjects with ≥ 1 TEAE, % SDZ-ADL-HCF: 49.4 SDZ-ADL-LCF: 56.5	Overall results (up to Day 72) HCF SDZ-ADL ADA: 69.1% nADA: 63.0% LCF SDZ-ADL ADA: 64.9% nADA: 61.3%
Real-world studies
8	Puig et al. 2022	Prospective registry study	SDZ-ADL	46 PsO pts biologic-naïve 90 PsO pts biologic-switch	Pts with PASI ≤ 2, % biologic-naïve vs. biologic-switch pts Month 6: 77.3 vs. 76.9 Month 12: 84.6 vs. 76.9 Pts with DLQI 0 or 1, % biologic-naïve vs. biologic-switch pts Month 6: 42.9 vs. 80.0 Month 12: 70.0 vs. 75.0	No. of events; IR/1000 (95% CI) PY Total serious events: 4; 31.5 (8.6; 80.7) Other serious infection: 2; 15.7 (1.9; 56.9) Malignant events: 0; 0.0 (0.0; 13.4)	–
9	Loft et al. 2021	Cohort study from a prospective registry (DERMBIO)	SDZ-ADL ref-ADL SB5	Patients with PsO Ref-ADL: 378 pts Switched from ref-ADL to SDZ-ADL: 186 pts Switched from ref-ADL to SB5: 162 pts	Change from baseline in PASI following switch, median (IQR) Switched to ADL biosimilar (SDZ-ADL and SB5 combined): 0.0 (–0.3 to 0.2) Continued ref-ADL: 0.0 (–0.3 to 0.2) Change from baseline in DLQI following switch, median (IQR) Switched to ADL biosimilar (SDZ-ADL and SB5 combined): 0.0 (–1.0 to 0.0) Continued ref-ADL: 0.0 (0.0 to 0.0)	Any AE, n (%) Switched to ADL biosimilar (SDZ-ADL and SB5 combined): 29 (9.1) Continued ref-ADL: 18 (5.0) Continued ref-ADL sensitivity cohort: 38 (10.5)	–
10	Nabi et al. 2021	Observational cohort study	SDZ-ADL SB5	SDZ-ADL: 214 RA pts 148 PsA pts 261 axSpA pts SB5: 253 RA pts 173 PsA pts 269 axSpA pts	1-year treatment withdrawal rate (age/gender adjusted) SDZ-ADL vs. SB5, HR (95% CI) RA: 0.50 (0.28; 0.90)* PsA: 0.97 (0.46; 2.02) AxSpA: 0.75 (0.42; 1.33) 6 months’ remission rate (fully adjusted) SDZ-ADL vs. SB5, OR (95% CI) RA: 1.81 (1.07; 3.06)* PsA: 1.79 (0.88; 3.66) AxSpA: 1.87 (1.04; 3.34)* Disease activity scores, median (IQR) DAS 28 RA baseline: 2.3 (1.7 to 2.8) 6 months post-switch: 2.0 (1.6 to 2.6) PsA baseline: 2.1 (1.6 to 2.6) 6 months post-switch: 1.9 (1.5 to 2.6) HAQ (0–3) RA baseline: 0.6 (0.2 to 1.1) 6 months post-switch: 0.6 (0.2 to 1.1) PsA baseline: 0.5 (0.1 to 0.9) 6 months post-switch: 0.5 (0.0 to 1.0) BASDAI, cm AxSpA: baseline: 2.5 (1.0 to 4.6) 6 months post-switch: 2.5 (1.1 to 4.5)	–	–
11	Colaci et al. 2021	Observational, single center study	SDZ-ADL	25 RA pts 32 PsA pts 31 axSpA pts	Disease activity scores, median (IQR) DAS28-CRP Baseline (ref ADL): 1.03 (0.96 to 3.43) 6 months post-switch: 1.21 (0.0 to 3.7) DAPSA Baseline (ref ADL): 0 (0.0 to 12.2) 6 months post-switch: 0 (0.0 to 15.0) BASDAI Baseline (ref ADL): 0 (0.0 to 4.3) 6 months post-switch: 0 (0.0 to 6.4) Retention rate: 93.2%	Disease reactivation n = 1 (1.1%), subjective/nocebo effect n = 5 (5.7%); (general malaise and transient increase of blood pressure n = 1; dizziness, paresthesia, arthralgia, headache n = 1; itch n = 1; subjective worsening n = 2)	Not assessed
12	Di Giuseppe et al. 2022	Observational cohort study	SDZ-ADL ref-ADL SB5 ABP 501 MSB11022	SDZ-ADL (ADL-naïve pts): 1044 428 RA pts 240 PsA pts 261 axSpA pts 115 other pts SDZ-ADL (pts switched from ref-ADL): 42 RA pts 53 PsA pts 60 axSpA pts 2 other pts ref-ADL (ADL-naïve pts): 2619 pts	1-year retention rate (all pts), % (95% CI) SDZ-ADL: 76 (71; 80) ref-ADL: 78 (77; 80) 1-year retention rate (switched pts), % (95% CI) ref-ADL to SDZ-ADL: 90 (79; 95) ref-ADL continued: 95 (88; 98)	–	–
13	Jyssum et al. 2023	Observational study (NOR-DMARD)	SDZ-ADL ref-ADL	SDZ-ADL: 64 SpA, 39 RA, 29 PsA, 6 other pts ref-ADL: 113 SpA, 59 RA, 41 PsA, 27 other pts	Responders at 3 months (SpA/RA/PsA/other), % SDZ-ADL: 49/72/79/80 ref-ADL: 48/61/61/63	–	Pts ADA-positive, n (%) SDZ-ADL: 6 (4) ref-ADL: 33 (14) p = 0.004
14	Mocci et al. 2022	Retrospective, multicenter study	SDZ-ADL ref-ADL	SDZ-ADL: 20 UC pts 42 CD pts ref-ADL: 21 UC pts 51 CD pts	Clinical remission rate, % SDZ-ADL: 82.3; ref-ADL: 75.0 (p = 0.31) Clinical response rate, % SDZ-ADL: 87.1; ref-ADL: 84.7 (p = 0.69) Mucosal healing rate, % SDZ-ADL: 89.2; ref-ADL: 60.0 (p = 0.003) (median follow-up time of 12 months)	AEs, n (%) UC Total AEs SDZ-ADL: 0 (0); ref-ADL: 2 (9.5) Severe AEs SDZ-ADL: 0 (0); ref-ADL: 1 (4.8) CD Total AEs SDZ-ADL: 1 (2.4); ref-ADL: 2 (3.9) Severe AEs SDZ-ADL: 1 (2.4); ref-ADL: 1 (2.0)	–
15	Wasserbauer et al. 2022	Prospective observational, multicenter study	SDZ-ADL FKB327	SDZ-ADL: 28 IBD pts FKB327: 22 IBD pts	Remission or partial response after 12 weeks, % SDZ-ADL: 75.0; FKB327: 81.8 (p = 0.73) CDAI in pts with CD treated with SDZ-ADL, median Baseline: 251.0; Week 12: 110.5 (p = 0.003) MSS value in pts with UC treated with SDZ-ADL, median Baseline: 8.0; Week 12: 4.0 (p = 0.01)	Total AEs: seven (for all treatments) Four mild complications (one patient each with skin eczema, COVID-19, mycotic infection, pneumonia) Two allergic reactions One neurologic complication	–
16	Gros et al. 2022	Prospective, observational study	SDZ-ADL	6 UC pts 34 CD pts	Pts in clinical remission at Month 9: 94.9% Laboratory values prior (pts on ref-ADL) and after switching to SDZ-ADL (median follow-up 10.6 months): ADL levels (7.7 vs. 5.9 mg/ml; p = 0.001) CRP levels (0.4 vs. 0.7 g/l; p = 0.02) Albumin levels (4.4 vs. 4.6 g/l; p = 0.02)	No severe AEs reported	–
17	Lontai et al. 2022	Prospective, observational, multicenter study	SDZ-ADL ref-ADL ABP 501 MSB11022	ref-ADL to SDZ-ADL switch: 174 IBD pts (41 UC, 133 CD) ADL biosimilars to SDZ-ADL switch: 102 IBD pts (30 UC, 72 CD)	Clinical remission rates, % ref-ADL to ADL biosimilar switch: pre-switch, 87.3; at switch, 88.5; Weeks 8–12, 86.5; Weeks 20–24, 85.7 ADL biosimilar to ADL biosimilar switch: pre-switch, 74.5; at switch, 78.4; Weeks 8–12, 85.3; Weeks 20–24, 79.8 Drug survival probability, % ± SE ref-ADL to ADL biosimilar switch: 20 weeks: 95.4 ± 1.6; 40 weeks: 91.6 ± 2.2 ADL biosimilar to ADL biosimilar switch: 20 weeks: 94.1 ± 2.3; 40 weeks: 87.0 ± 3.4	Treatment-related AEs Five events in five pts Two skin erythema (1 SDZ-ADL, 1 MSB11022) One liver enzyme elevation (SDZ-ADL) One ADL-induced psoriasis (SDZ-ADL) One late hypersensitivity (SDZ-ADL)	-
18	Tursi et al. 2022	Retrospective, observational, multicenter study	SDZ-ADL ABP 501 SB5 MSB11022	Pts switched from ref-ADL to: SDZ-ADL: 7 IBD pts ABP 501: 78 IBD pts SB5: 65 IBD pts MSB11022: 3 IBD pts	Maintenance of remission in switched patients after median follow-up of 12 months, % SDZ-ADL: 66.7 (n = 4/7) ABP 501: 84.6 (n = 66/78) SB5: 78.5 (n = 51/65) MSB11022: 100 (n = 3/3)	Total AEs SDZ-ADL: one mild-moderate allergy	–
19	Tursi et al. 2023	Retrospective, observational, multicenter study (same study as Tursi 2022)	SDZ-ADL ABP 501 SB5 MSB11022	Switched and naïve pts treated with: SDZ-ADL: 49 IBD pts (13 UC, 36 CD) ABP 501: 259 IBD pts SB5: 214 IBD pts MSB11022: 11 IBD pts	Clinical remission obtained or maintained (all patients), % SDZ-ADL, 77.5; ABP 501, 78.3; SB5, 75.2; MSB11022, 81.8 Clinical remission obtained (biologic-naïve pts), % SDZ-ADL, 82.1; ABP 501, 77.7; SB5, 80.2; MSB11022, 100 Clinical remission maintained (switched pts), % SDZ-ADL, 66.7; ABP 501, 83.5; SB5, 78.5; MSB11022, 100 Clinical response obtained or maintained (all patients), % SDZ-ADL, 91.8; ABP 501, 89.3; SB5, 90.2; MSB11022, 90.9	Total AEs SDZ-ADL: one (2.0%; allergy)	–
ACR American College of Rheumatology, ADA anti-drug antibody, ADL adalimumab, AE adverse event, AUC area under the curve, axSpA axial spondyloarthritis, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, CD Crohn’s disease, CDAI Crohn’s Disease Activity Index, CI confidence interval, C_max maximum concentration, COVID-19 coronavirus disease 2019, CRP C-reactive protein, DAPSA Disease Activity Index for Psoriatic Arthritis, DAS28 Disease Activity Score (four variables), DLQI Dermatology Life Quality Index, EQ-5D-5L Euro-QoL five-dimensional five-level, EU European Union, FACIT Functional Assessment of Chronic Illness Therapy, GMR geometric mean ratio, HAQ Health Assessment Questionnaire, HAQ-DI Health Assessment Questionnaire-Disability Index, HCF high-concentration formulation, HR hazard ratio, IBD inflammatory bowel disease, IQR interquartile range, IR incidence rate, LCF low-concentration formulation, LSM least squares mean, MRI magnetic resonance imaging, mSASSS modified Stoke Ankylosing Spondylitis Spinal Score, MSS Mayo scoring system, nADA neutralizing anti-drug antibody, OR odds ratio, PASI Psoriasis Area and Severity Index, PK pharmacokinetics, PRO patient-reported outcome, PsA psoriatic arthritis, PsO psoriasis, pt patient, PY patient-year, RA rheumatoid arthritis, ref-ADL reference-adalimumab, SAE serious adverse event, SD standard deviation, SDZ-ADL Sandoz-adalimumab, SE standard error, SEC secukinumab, SIJ sacroiliac joint, TEAE treatment-emergent adverse event, UC ulcerative colitis, US United States, Wk week *p < 0.05. Δ = treatment difference

References:
[1] [1] Adapted from: Wiland P, Both C, Gaylis NB, Cohen RD, Halfvarson J, Lemke L, von Richter O, Blauvelt A. Efficacy, Safety, and Immunogenicity of SDZ-ADL, an Adalimumab Biosimilar, in Biologic-Nave and Switched Patients with Immune-Mediated Inflammatory Diseases: A Literature Review. Adv Ther. 2025 Mar;42(3):1360-1392. doi:10.1007/s12325-024-03098-z.