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Big Molecule Watch
March 5, 2026

FDA Accepts Dr. Reddy’s Laboratories’ BLA for Abatacept Biosimilar

Dr. Reddy’s Laboratories (“Dr. Reddy’s”) announced on February 22 that the FDA accepted its BLA for DRL_AB, a proposed interchangeable biosimilar to Bristol-Myers Squibb’s ORENCIA® (abatacept) IV for infusion. According to the press release, abatacept works as a selective co-stimulation modulator and functions by binding to specific proteins on immune cells (CD80 and CD86), which blocks a key signal required for the full activation of T lymphocytes. Overactive T lymphocytes play a role in driving the inflammation seen in rheumatoid arthritis (“RA”), polyarticular juvenile idiopathic arthritis (“pJIA”) and psoriatic arthritis (“PsA”). If approved, DRL_AB will be indicated for the treatment of adults with moderately-to-severely active RA, adults with active PsA, and individuals aged six years and above with moderately-to-severely active pJIA.

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