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

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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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