Kashiv Biosciences' Abatacept Biosimilar KSHB002 Meets Primary Endpoints in Phase I Trial
• Kashiv Biosciences announced that KSHB002, an abatacept biosimilar candidate, met its primary endpoints in a Phase I clinical trial, demonstrating pharmacokinetic equivalence to Orencia.
• The randomized, open-label study with 300 healthy adults showed KSHB002's maximum serum concentration (Cmax) and AUC fell within the 80-125% bioequivalence range.
• Safety and immunogenicity profiles of KSHB002 were comparable to Orencia, supporting its further development as a subcutaneous and intravenous formulation.
• Kashiv Biosciences is advancing KSHB002 into a global Phase III efficacy and safety trial for patients with rheumatoid arthritis.
Kashiv BioSciences and Amneal Pharmaceuticals Partner for Omalizumab Biosimilar
• Kashiv BioSciences has entered an exclusive licensing agreement with Amneal Pharmaceuticals for ADL018, a biosimilar to omalizumab (XOLAIR®), for the U.S. market.
• ADL018, currently in Phase III clinical trials, targets free IgE and is intended for conditions like allergic asthma and chronic rhinosinusitis with nasal polyps.
• This partnership builds on the existing collaboration between Kashiv and Amneal, following the successful U.S. biosimilar launches of RELEUKO® and FYLNETRA®.
• Omalizumab (XOLAIR®) had approximately $3.2 billion in U.S. sales for the 12 months ending April 2024, according to IQVIA®.
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