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Data-Backed Celltrion Looks To File Xolair Biosimilar ‘This Year’

Bumper Year Planned, With Up To Five Filings On Company’s Agenda

 
• By Dean Rudge

Likely frontrunner Celltrion has published 24-week Phase III data for its CT-P39 biosimilar Xolair candidate, which tees up a planned biosimilar filing later this year.

Celltrion_Magnified
• Source: Shutterstock

Celltrion looks set to emerge as potentially one of the first filers worldwide for a biosimilar to Genentech/Novartis’ Xolair (omalizumab) blockbuster, after publishing 24-week Phase III clinical comparative data which it says confirms equivalence between the branded treatment for allergic asthma and chronic idiopathic urticaria and the Korean firm’s CT-P39 biosimilar candidate.

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Cardinal Looks Ahead To A New Decade For US Biosimilars

 
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• By Dave Wallace

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Biocon Chooses To Settle Over Eylea In US – Will Others Follow?

 
• By Dave Wallace

After Amgen’s surprise launch of the first US biosimilar to Eylea last year, expectations around competition are being further upended with the news that Biocon Biologics has struck a settlement deal with Regeneron allowing it to launch its own aflibercept rival in the second half of 2026. Will other challengers follow suit?

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Coherus Marks Exit From Biosimilars By Completing Udenyca Divestment

 
• By Dave Wallace

Coherus has officially marked its exit from biosimilars by completing the divestment of its Udenyca pegfilgrastim franchise. Meanwhile, buyer Accord BioPharma has set out how it expects to benefit not only from a growing asset but also from the Coherus personnel that have moved over.

Sandoz Admits To Widescale Infringement In Resolving US Rinvoq Patent Tussle

 
• By Dean Rudge

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Biocon Chooses To Settle Over Eylea In US – Will Others Follow?

 
• By Dave Wallace

After Amgen’s surprise launch of the first US biosimilar to Eylea last year, expectations around competition are being further upended with the news that Biocon Biologics has struck a settlement deal with Regeneron allowing it to launch its own aflibercept rival in the second half of 2026. Will other challengers follow suit?