FDA accepts Dr. Reddy's biosimilar abatacept application for review
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Dr. Reddy’s Announces USFDA Acceptance to Review Its Biologics License Application (BLA) for Proposed Interchangeable Biosimilar, Abatacept
February 20, 2026 10:57 AM ESTFollowing 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
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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
