Celltrion Goes It Alone With First Solo US Biosimilar Launch

Vegzelma Is The Fourth FDA-Approved Bevacizumab Rival To Avastin

Celltrion is taking a major step forward in the US with its first direct launch of a biosimilar through its own front-end operation. The Korean firm’s Vegzelma rival to Avastin will be looking to compete with multiple other versions of bevacizumab already in the market.

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Celltrion is striking out on its own with the launch of Vegzelma

Celltrion has marked a milestone by executing its first US biosimilar launch through its own commercialization operations, with the introduction of its Vegzelma (bevacizumab-adcd) rival to Avastin, according to Korean media reports.

Having previously collaborated with US marketing partners for its biosimilars – such as Teva on Truxima (rituximab-abbs) and Herzuma (trastuzumab-pkrb),...

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An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.

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