Dr. Reddy’s Announces USFDA Acceptance to Review Its Biologics License Application (BLA) for Proposed Interchangeable Biosimilar, Abatacept
Dr. Reddy's Laboratories Ltd (RDY)
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drreddys.com/investors
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Source: Business Wire
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 HYDERABAD, India--(BUSINESS WIRE)--Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”), today announced that the US Food and Drug Administration (USFDA) has accepted for review, its 351 (k) Biologics License Application (BLA) IV for infusion formulation for DRL_AB, a proposed interchangeable biosimilar to ORENCIA® (abatacept) that was submitted in December 2025."We are proud to be the first to submit a BLA for an abatacept biosimilar which marks a significant milestone in our mission to increase patient access to critical, high-qu
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News
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- Dr. Reddy's Laboratories (NYSE:RDY) was downgraded by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a> from a "buy (b-)" rating to a "hold (c+)" rating.MarketBeat
- Dr. Reddy's Laboratories (NYSE:RDY) was upgraded by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a> from a "hold (c+)" rating to a "buy (b-)" rating.MarketBeat
- Coya Therapeutics raises $11.1M in private placement led by Dr. Reddy's [Seeking Alpha]Seeking Alpha
- Dr Reddy's Laboratories Ltd (RDY) Q3 2026 Earnings Call Highlights: Navigating Growth Amidst ... [Yahoo! Finance]Yahoo! Finance
RDY
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- 1/22/26 - Beat
RDY
Sec Filings
- 2/18/26 - Form 6-K
- 2/17/26 - Form 6-K
- 2/12/26 - Form 6-K
- RDY's page on the SEC website