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Biocon Biologics

Biocon Biologics Reports the US FDA’s Approval of Yesintek (Biosimilar, Stelara) 

Shots:  The US FDA has granted approval to the company’s Yesintek, a biosimilar version of J&J’s Stelara (ustekinumab)  Biocon Biologics will commercialize Yesintek across the US by Feb 22, 2025, following FDA approval, under a settlement and licensing agreement with Janssen  Yesintek is a monoclonal antibody indicated for the treatment of Crohn’s disease, Ulcerative Colitis,…

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Celltrion

Celltrion’s Steqeyma (Biosimilar, Stelara) Receives the Health Canada’s Approval to Treat Various Chronic Inflammatory Conditions 

Shots:  Health Canada has approved Steqeyma injection & Steqeyma I.V. (injection, solution for IV infusion), biosimilar versions of Stelara (ustekinumab) to treat adults with moderate to severe active Crohn’s disease & plaque PsO as well as active psoriatic arthritis  Approval was supported by the P-III trial of Steqeyma vs Stelara, with the 1EP as rate…

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