KSHB002 (abatacept biosimilar) / Amneal - LARVOL DELTA

Kashiv Biosciences Announces Successful Phase 1 Results for Abatacept Biosimilar Candidate, KSHB002 (Businesswire) - P1 | N=300 | "Kashiv Biosciences...today announced that their abatacept biosimilar candidate, KSHB002, has successfully met the primary endpoints in its Phase 1 clinical trial. The trial demonstrated pharmacokinetic equivalence to the US-licensed and EU-authorized reference product, ORENCIA....The results demonstrated that both primary endpoints, maximum serum concentration (Cmax) and area under the concentration-time curve from time zero to infinity (AUC₀–∞), were within the 80-125% bioequivalence range, confirming pharmacokinetic equivalence. Furthermore, the safety and immunogenicity profiles of KSHB002 were comparable to those of ORENCIA....This represents a pivotal step in advancing the evaluation of KSHB002 for patients with rheumatoid arthritis."

P1 data • Rheumatoid Arthritis