Dr. Reddy's Laboratories (RDY) said Friday the US Food and Drug Administration has accepted for review its biologics license application for an IV infusion formulation of DRL_AB, a proposed biosimilar to Orencia, or abatacept.
Abatacept is a medication used to treat moderate to severe autoimmune diseases, including rheumatoid arthrities, psoriatic arthritis and juvenile idiopathic arthritis.
Following approval, the company said DRL_AB will be administered as an IV for infusion to treat adults with moderate to severely active rheumatoid arthritis, adults with active psoriatic arthritis, and individuals aged six years and older with moderate to severely active polyarticular juvenile idiopathic arthritis.
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