On 20 February 2026, Dr Reddy’s Laboratories announced that its Biologics Licence Application (BLA) for DRL_AB, biosimilar to BMS’ Orencia® (abatacept), has been accepted for review by the FDA. Dr Reddy’s expects regulatory approval in the US at the end of 2026 for the IV formulation and in early 2028 for the subcutaneous formulation.
DRL_AB (IV) is proposed for the following indications: adults with moderate to severe active rheumatoid arthritis, active psoriatic arthritis and active polyarticular juvenile idiopathic arthritis in patients aged 6 and above.
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)).
Kashiv Biosciences is also developing biosimilar abatacept, with the successful completion of a phase 1 clinical trial of KSHB002 announced in January 2025.