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Will All US Biosimilar mAbs Be Interchangeable In The Long Run?

Landmark Adalimumab Approval Sparks Debate For Controversial Designation

 
• By Dean Rudge

As Boehringer Ingelheim’s Cyltezo has become the second-ever interchangeable biosimilar approved by the US FDA – as well as the first monoclonal antibody to garner the designation and offering the first published data from a switching trial to support interchangeability – the debate around the potential impact for interchangeable products in the keenly-watched adalimumab space and beyond continues to grow.

dawn
Will the landmark approval mark a new dawn for biosimilar mabs? • Source: Alamy

Boehringer Ingelheim’s landmark first approval for an interchangeable biosimilar monoclonal antibody raises the question “if in the long run, interchangeable biosimilars will be the only biosimilars” for such class of biologics, posits Bernstein Research’s Ronny Gal.

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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

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?