On 28 January 2025, Kashiv Biosciences announced that KSHB002, biosimilar to BMS’ Orencia® (abatacept), met the primary endpoints in its phase 1 clinical trial. According to Kashiv, the trial demonstrated pharmacokinetic equivalence between KSHB002 and US-licensed and EU-authorised Orencia® and confirmed that the safety and immunogenicity profiles of KSHB002 were comparable to those of the BMS reference product.
In the phase 1 trial, a 125 mg/mL pre-filled syringe injection of the abatacept biosimilar was evaluated in 300 healthy adults, with each participant receiving a single subcutaneous dose. Kashiv now intends to proceed with a phase 3 efficacy and safety trial.
Orencia® is approved in the US and EU including for the treatment of adults with moderately to severely active rheumatoid arthritis (RA), patients 2 years and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) and patients 2 years and older with active psoriatic arthritis (PsA). It is available in both IV (adults and paediatric patients) and SC (adults only) forms. Kashiv is developing KSHB002 in both subcutaneous and intravenous forms.
An abatacept biosimilar is also being developed by Dr Reddy’s. 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).