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Celltrion Eyes Near-Term Omalizumab Opportunity With CHMP Backing

Korean Firm’s Omlyclo Biosimilar To Xolair First Recommended For EU Approval

 
• By Dean Rudge

The pool of prospective Xolair biosimilars is small, with only Teva and Kashiv BioSciences/Alvotech disclosing Phase III comparison trials for their biosimilar products. Ahead of them in the pack, Celltrion has just taken a giant stride towards the first pan-European marketing approval.

Celltrion website logo
• Source: Shutterstock

Celltrion has emerged as the first company to win an EU recommendation for a marketing approval for a biosimilar to Genentech/Novartis’s Xolair (omalizumab), setting up a potential near-term launch with key Xolair compound and formulation patents having already expired or imminently about to run their course.

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