| Drug Name |
SELARSDI™(ustekinumab-aekn) |
| Active Ingredient |
ustekinumab-aekn |
| Date of Approval |
04/16/24 |
| Manufacturer |
Alvotech and Teva Pharmaceuticals |
| Approval Pathways and Indications |
Indications:
Adult patients with:
• moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy
• active psoriatic arthritis (PsA)
Pediatric patients 6 years and older with:
• moderate to severe PsO who are candidates for phototherapy or systemic therapy
• active PsA
Approval Pathway: BLA |
| Therapeutic Class |
Antipsoriatic Agent; Interleukin-12 Inhibitor; Interleukin-23 Inhibitor; Monoclonal Antibody |
| Formulation |
Subcutaneous Injection |
| MoA |
Ustekinumab products are human IgG1қ monoclonal antibodies that bind with specificity to the p40 protein subunit used by both the IL-12 and IL-23 cytokines. IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. |
| Dosing and Administration |
Injection: 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe.
Subcutaneous Adult Dosage Regimen:
• For patients weighing 100 kg or less, the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
• For patients weighing more than 100 kg, the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.
In subjects weighing more than 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these subjects. |
| Administered by self or by HCP |
SELARSDI™ is intended for use under the guidance and supervision of a healthcare provider. SELARSDI™ should only be administered to patients who will be closely monitored and have regular follow-up visits with a healthcare provider. The appropriate dose should be determined by a healthcare provider using the patient’s current weight at the time of dosing. In pediatric patients, it is recommended that SELARSDI™ be administered by a healthcare provider. If a healthcare provider determines that it is appropriate, a patient may self-inject or a caregiver may inject SELARSDI™ after proper training in subcutaneous injection technique. |
| Place in Therapy |
SELARSDI™ is indicated for the treatment of moderate to severe PsO and for active PsA in adults and pediatric patients 6 years and older. Under the strategic partnership between Teva and Alvotech, Teva is responsible for the exclusive commercialization of SELARSDI™ in the United States.
SELARSDI™ was developed and is manufactured by Alvotech using murine cell (Sp2/0) and a continuous perfusion process, which are the same type of cells and process used for the production of Stelara®.
SELARSDI™ has the opportunity to improve patient access to a biologic in inflammatory disease, while simultaneously accounting for lower healthcare costs. This could lead to cost savings across healthcare systems and introduce additional treatment options for patients.
In the United States, PsO is the most common form of psoriasis while PsA accounts for approximately six percent of all cases of juvenile arthritis, indicating this therapy could prove to be beneficial.
At this point, it's premature to determine whether this product offers more or fewer benefits, in terms of effectiveness, safety, and cost-effectiveness, compared to other ustekinumab products. |
| Expected Market Launch Date |
SELARSDI™ is expected to be marketed in the United States on or after February 21, 2025, following a settlement agreement with Johnson & Johnson, the manufacturer of Stelara®. |
| New Molecular Entity (NME) or Existing Formulation |
Existing Formulation (biosimilar) |
| Expected Cost |
Unavailable |
| Product Discontinuation |
N/A |
| Clinical Trials |
The approval of SELARSDI™ was based on a totality of evidence, including data from a phase 3 randomized, double-blind, multicenter study (ClinicalTrials.gov Identifier: NCT04930042) that compared the efficacy and safety of SELARSDI™ to the reference product, Stelara®, in patients with moderate to severe PsA. Results showed the products were therapeutically equivalent, meeting the primary endpoint for psoriasis area and severity index percent improvement from baseline to week 12.
The approval was also supported by data from a phase 1 study (ClinicalTrials.gov Identifier: NCT04744363) that compared the pharmacokinetic, safety, tolerability, and immunogenicity of SELARSDI™ administered as a single 45mg/0.5mL subcutaneous injection to Stelara®. Findings showed bioequivalence between SELARSDI™ and the reference product. |
| Sources |
1. Alvotech and Teva announce U.S. FDA approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab). Alvotech. (2024, April 16). https://investors.alvotech.com/news-releases/news-release-details/alvotech-and-teva-announce-us-fda-approval-selarsditm |