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Sandoz’s High-Concentration Humira Biosimilar Lands On FDA’s Desk

SBLA Follows EMA Accepting Proposed Biosimilar For Filing In June

 
• By Dean Rudge

Sandoz has named its three most promising upcoming biosimilar launches, ahead of filing its proposed high-concentration version of adalimumab with the US Food and Drug Administration.

FDA website
Sandoz's filing is now with both the US and EU regulators • Source: Shutterstock

Sandoz has followed swiftly its proposed higher strength biosimilar version of Humira (adalimumab) being accepted for filing by the European Medicines Agency, with a corresponding filing in the US.

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

 
• By Dave Wallace

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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

Sandoz has reached an agreement with AbbVie to dismiss without prejudice patent-infringement litigation involving more than 20 patents shielding the originator’s blockbuster JAK inhibitor Rinvoq.

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?