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Sandoz Faces US Denosumab Lawsuit Ahead Of Key 2025 Patent Expiry

Sandoz’s BLA Accepted For FDA Review In February; Denosumab Sales In Billions

 
• By Dean Rudge

Months after announcing that its GP2411 biosimilar denosumab candidate was accepted for filing by the FDA, Sandoz has been sued for alleged patent infringement by originator Amgen.

Grechanyuk Aleksandr/Alamy Stock Photo
• Source: Shutterstock (Grechanyuk Aleksandr / Alamy Sto/Alamy Stock Photo)

Sandoz may have to defend itself from patent infringement claims in a US district court after being sued by Amgen in response to Sandoz filing for a biosimilar to the originator’s Prolia/Xgeva (denosumab).

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Cardinal Looks Ahead To A New Decade For US Biosimilars

 
• 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.

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?