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Celltrion’s Rituximab Biosimilar Is The First Greenlit By The FDA

 
• By Dean Rudge

Truxima (rituximab-abbs) becomes the first biosimilar to Rituxan approved by the US agency, although launch timing remains unclear; Celltrion also has novel infliximab subcutaneous formulation accepted for review by the EMA.

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FDA gives Truxima the green light

The first biosimilar with non-Hodgkin’s lymphoma (NHL) indications, Celltrion’s Truxima (rituximab-abbs), has passed the US Food and Drug Administration (FDA) approval process, becoming also the first Rituxan (rituximab) biosimilar authorised in the US.

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Cardinal Looks Ahead To A New Decade For US Biosimilars

 
• By Dave Wallace

In the wake of a report marking 10 years since the first US biosimilar launch, Cardinal Health’s Dracey Poore speaks to Generics Bulletin about the successes seen so far and the obstacles that must be overcome if the market is to thrive in the decade ahead.

Regulatory Recap: UK To Capture £1bn Savings With Framework For Best-Value Biologics

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.

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?

More from Products

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?