Dr. Reddy’s USFDA to Review Biologics License Application for Proposed Interchangeable Biosimilar

 

• Following the submission in December 2025, USFDA has accepted Dr. Reddy’s 351(k) Biologics License Application (BLA) for Proposed Interchangeable biosimilar Abatacept, DRL_AB (IV for Infusion)
• BLA is based on a robust data package supporting similarity to Orencia® (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data

https://www.morningstar.com/news/business-wire/20260220372110/dr-reddys-announces-usfda-acceptance-to-review-its-biologics-license-application-bla-for-proposed-interchangeable-biosimilar-abatacept