In its Q3/FY26 earnings call on 21 January 2026, Dr Reddy’s announced that its abatacept biosimilar, referencing BMS’ Orencia®, is expected to be approved in the US at the end of 2026 in IV form and in early 2028 in a subcutaneous formulation, with launches soon after those dates. In Europe, Dr Reddy’s is aiming to simultaneously launch both IV and SC abatacept after expected approval in July 2027.
According to pipeline information on Dr Reddy’s website, its abatacept biosimilar has completed phase 1 clinical trials and phase 3 trials are underway.
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)).
An abatacept biosimilar is also being developed by Kashiv Biosciences, which announced the successful completion of a phase 1 clinical trial of KSHB002 (abatacept) in January 2025.