Abatacept Approval Strengthens Biosimilar Pipeline

Laboratories has received approval from India’s CDSCO to manufacture and market its abatacept biosimilar for moderate-to-severe rheumatoid arthritis and active psoriatic arthritis. The approval covers the intravenous 250 mg presentation and requires the company to conduct a post-marketing study in India. The larger opportunity lies in the US market. Dr. Reddy’s has already filed the Biologics License Application (BLA) for abatacept and the USFDA's target action date is in mid-December 2026. Management has indicated that the product is planned to be launched from its own Bachupally facility if approved. Abatacept is a biosimilar to Bristol Myers Squibb's Orencia, used primarily in autoimmune conditions. A US approval would provide Dr. Reddy's access to a higher-value biologics opportunity and strengthen its position in the US biosimilars market.