Mylan Obtains CHMP Backing For Revlimid Generic In Two Indications

Accord Already Holds Final Approval For Lenalidomide Generic

Mylan is taking aim at a lucrative oral solid formulation in Europe, with the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending approval for the company’s generic version of Revlimid (lenalidomide) capsules.

3d render of Europe map Earth globe
Mylan's generic lenalidomide product was backed by the CHMP • Source: Shutterstock

Mylan has been backed by the European Medicines Agency’s Committee for Medicinal Products for Human Use to receive a pan-European marketing authorization for the US firm’s generic to Celgene’s Revlimid (lenalidomide) capsules to treat multiple myeloma and follicular lymphoma.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Generics

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

 

Generics Bulletin reviews global regulatory developments across the world.

Aurobindo Plots Rivaroxaban Roll-Out As FDA Approves 2.5mg Strength ANDA

 
• By 

Aurobindo is set to join Lupin by competing against Johnson/Bayer’s blockbuster blood thinner Xarelto (rivaroxaban) 2.5mg tablets.

Tevogen Launches Generics-Focused Initiative As Trump Eyes Pharma Tariffs

 
• By 

As the Trump Administration continues to send ripples across industries, Tevogen has launched a new generic drugs-focused endeavor that plans to reshore production to the US.

Sandoz Admits To Widescale Infringement In Resolving US Rinvoq Patent Tussle

 
• By 

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.

More from Products

Coherus Marks Exit From Biosimilars By Completing Udenyca Divestment

 
• By 

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 

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 

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?