Dr. Reddy's Announces USFDA Acceptance to Review Its Biologics License Application (BLA) for Proposed Interchangeable Biosimilar, Abatacept
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High Materiality8/10
Information
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
Original sourceAI Summary
Dr. Reddy's Laboratories has received USFDA acceptance for its biosimilar DRL_AB, aimed at providing a cost-effective alternative to Orencia for treating rheumatoid arthritis. With robust supporting data, this milestone could significantly boost RDY's market position and revenue potential in the immunology sector.
Sentiment Rationale
Acceptance of the BLA is a key step towards commercialization, which could lead to increased revenues. Historical patterns show biosimilar approvals typically result in stock price appreciation.
Trading Thesis
Bullish on RDY in the next 12 months due to expected approval and market entry of DRL_AB.
Market-Moving
- FDA approval could lead to near-term revenue growth for RDY.
- Successful launch of DRL_AB could expand RDY's market share in biosimilars.
- Intensifying competition in the biosimilar space could affect earnings projections.
Key Facts
- USFDA has accepted Dr. Reddy's BLA for DRL_AB biosimilar.
- BLA submission included comprehensive data supporting similarity to Orencia.
- DRL_AB will treat active rheumatoid arthritis and psoriatic arthritis.
- Phase 3 study comparing DRL_AB and Orencia is ongoing.
- First submission of an abatacept biosimilar marks a significant milestone.
Companies Mentioned
- Bristol-Myers Squibb Company (BMY): Originator of Orencia, potential competition will remain a factor.
Corporate Developments
The article falls under 'Corporate Developments' as it highlights a significant regulatory milestone for Dr. Reddy's, which has implications for its product pipeline and revenue growth in the biosimilars market.