Pfizer Reports the US FDA’s Acceptance for Review the Prior Approval Supplement to the BLA for Abrilada (biosimilar, adalimumab) to Treat of Chronic Inflammatory Conditions
Shots:
- The US FDA has accepted PAS to BLA for Abrilada as an interchangeable biosimilar to Humira (adalimumab) with an anticipated BsUFA date for FDA decision in Q4’22. The therapy is expected to be available in the US in July 2023
- The PAS was based on the (REFLECTIONS B538-12) study to evaluate multiple switches of Abrilada vs Humira as administered with methotrexate in patients with RA. The study met its 1EPs i.e., the therapy showed Pk equivalence in patients who switched multiple times b/w treatments, no clinical differences in efficacy, safety, or immunogenicity were observed
- Abrilada is a citrate-free biosimilar to Humira & has been approved in the US for RA, JIA, PsA, AS, CD, UC & PsO
Ref: Pfizer | Image: Pfizer
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
