On 26 August 2026, the Economic Times reported that India’s CDSCO has approved Dr Reddy’s biosimilar to BMS’ Orencia® (abatacept) for the treatment of moderate to severely active rheumatoid arthritis and active psoriatic arthritis in patients who have responded inadequately to other disease-modifying antirheumatic drugs. The approval is conditional on Dr Reddy’s submitting a Phase IV trial protocol within three months and conducting the study in India.
Dr Reddy’s will manufacture the abatacept biosimilar at its biologics facility in Bachupally, India and has partnered with Gland Pharma in relation to the supply of the product.
Dr Reddy’s BLA for DRL_AB (abatacept) is currently under review by the FDA, with Dr Reddy’s expecting FDA approval at the end of 2026 for the IV formulation and in early 2028 for the subcutaneous formulation.
In March 2023, Dr Reddy’s entered an exclusive worldwide agreement with Coya Therapeutics, under which Coya is licensed to use Dr Reddy’s abatacept biosimilar to develop and commercialise a subcutaneous combination product, COYA 302 (abatacept with COYA-301, Coya’s low-dose interleukin-2 (IL-2)). Coya Therapeutics is currently recruiting for a Phase2/3 study of COYA 302 in patients with Amyotrophic Lateral Sclerosis.
Biosimilar abatacept is also under development by Amneal, with the successful completion of a phase 1 clinical trial of KSHB002 announced in January 2025. Amneal recently indicated that is expecting regulatory approval for its abatacept biosimilar in 2028-2030.