1. Generics Bulletin
  2. >>Products
  3. >>Generics

Mylan Obtains CHMP Backing For Revlimid Generic In Two Indications

Accord Already Holds Final Approval For Lenalidomide Generic

 
• By Dean Rudge

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.

Announcing its recommendation for Lenalidomide Mylan, the CHMP said studies demonstrated “the satisfactory quality of Lenalidomide Mylan and its bioequivalence...

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
Start Free Trial

Already a subscriber?

More from Generics

Latest EMA Biosimilar Nods Come For Henlius, Alteogen And Biocon

 
• By Dave Wallace

Denosumab, aflibercept and ustekinumab biosimilars received positive opinions from the EMA’s CHMP at its meeting in July, along with an Opsumit generic from Accord.

The Generics Bulletin Top 50, Part Two: Leading Players Leapfrog The Competition

 
• By Dave Wallace

In the second instalment of Generics Bulletin’s Top 50 ranking for 2025, we see plenty of movement among our mid-table collection of companies.

Gateway To Africa: Natco Bids For 35.75% Of Adcock Ingram

 
• By Anju Ghangurde

Natco to buy out Adcock Ingram’s minority shareholders in what’s possibly its biggest M&A investment, opening up substantial opportunities in South Africa and the region. If the offer goes through, it will result in the delisting of Adcock, with Bidvest and Natco co-owning the firm.

The Generics Bulletin Top 50, Part One: German Giants Rise Up The Ranks

 
• By Dave Wallace

Two leading German generics and biosimilars giants were the big movers in our top ten ranking of off-patent industry leaders for 2025. We reveal the latest developments among the top players in the first instalment of this year’s Generics Bulletin Top 50.

More from Products

Sun Strikes Further US Price-Fixing Settlement For $200m

 
• By Dave Wallace

The latest development in the long-running US generic price-fixing saga has seen Sun Pharma agree a $200m settlement in connection with an end purchaser action in Pennsylvania.

Just One Week To Go! Entry Deadline Looms For GGB Awards 2025

 
• By Dave Wallace

There is now just one week left to submit entries to the Global Generics & Biosimilars Awards 2025, with the entry deadline set for August 1.

UK Xtandi Patent Stands Strong As Accord, Sandoz, Teva Lose Appeal

 
• By Dean Rudge

The Court of Appeal in London has upheld a key UK patent shielding Astellas’ Xtandi, rejecting claims by a trio of generic drugmakers that it was obvious after finding that the generics firms’ expert analysis was tainted by hindsight.