FDA accepts Dr. Reddy's biosimilar abatacept application for review

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Go back to FDA accepts Dr. Reddy's biosimilar abatacept application for review

Dr. Reddy’s Announces USFDA Acceptance to Review Its Biologics License Application (BLA) for Proposed Interchangeable Biosimilar, Abatacept

February 20, 2026 10:57 AM EST

Following the submission in December 2025, USFDA has accepted Dr. Reddys 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

 

HYDERABAD, India--(BUSINESS WIRE)-- Dr. Reddys Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as Dr. Reddys), today announced that the US Food and Drug Administration (USFDA) has accepted for review,... More