Dr. Reddy’s Laboratories has announced that the US Food and Drug Administration (USFDA) has accepted its Biologics License Application (BLA) for an interchangeable biosimilar of abatacept (DRL_AB IV infusion). The application, submitted in December 2025, is supported by comprehensive data demonstrating similarity to Orencia®, marking a key milestone in biosimilars.
Dr. Reddy’s Laboratories has achieved a significant regulatory milestone with the USFDA’s acceptance of its Biologics License Application (BLA) for DRL_AB, a proposed interchangeable biosimilar to abatacept. This development strengthens the company’s position in the global biosimilars market and underscores its commitment to expanding access to advanced biologic therapies.
Key Highlights
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Acceptance of the 351(k) BLA submission made in December 2025
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Application covers DRL_AB (IV infusion), designed as an interchangeable biosimilar to Orencia® (abatacept)
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Data package includes pharmacokinetic, clinical, and analytical evidence supporting similarity and interchangeability
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Potential therapeutic use in autoimmune conditions such as rheumatoid arthritis
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Represents a step toward broader patient access to cost-effective biologic treatments in the US market
The USFDA’s review of this application is expected to pave the way for increased competition in the biologics segment, potentially reducing healthcare costs while maintaining treatment efficacy and safety standards.
Sources: Business Wire, Morningstar