1. Generics Bulletin
  2. >>Products

Krka, Accord And Xeris Pick Up European Nods

Rivals To Revlimid And Sutent Accompanied By GlucaGen Hybrid

 
• By Dave Wallace

The EMA’s CHMP has recommended granting pan-European marketing authorizations for Krka’s lenalidomide versions of Revlimid and Accord’s sunitinib rival to Sutent, as well as Xeris Pharmaceuticals’ glucagon hybrid rival to Glucagen.

Thumbs up
Three firms received CHMP endorsements for generics and hybrid medicines • Source: Shutterstock

December’s meeting of the Committee for Medicinal Products for Human Use within the European Medicines Agency has resulted in a trio of positive opinions recommending the granting of marketing authorizations for generic and hybrid medicines.

Krka has received CHMP endorsement for its generic version of Bristol Myers Squibb’s Revlimid (lenalidomide), with the Slovenian company choosing to register its version through three different marketing authorization applications with differing

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 Products

Tetris Deal Falls Into Place For UK’s Aspire

 
• By Dave Wallace

Niche generics company Aspire Pharma has struck a deal to acquire a portfolio of products from fellow UK firm Tetris Pharma as it is wound up, paying Tetris parent Arecor £0.5m for UK distribution rights and inventory.

Apotex Extends Formosa Ophthalmic Alliance Into Mexico

 
• By Dave Wallace

Apotex has expanded an alliance formed with Formosa in August for its novel clobetasol propionate ophthalmic treatment, adding Mexican rights to its existing deal for the Canadian market.

Fresenius Kabi Lauds Tocilizumab Momentum As ‘Intense’ Transfer To mAbxience Continues

 
• By Dean Rudge

Fresenius Kabi continued to reap the rewards of its fledgling commercial Biopharma business in the first quarter, as the firm eyes further growth for its tocilizumab biosimilar in the US and Europe in the second half of 2025.

US FDA Expands Surprise Foreign Inspections

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

More from Generics Bulletin

After Jazz, Hikma Agrees $50m Settlement For ‘Most’ Xyrem ‘Pay-For-Delay’ Claims

 
• By Dean Rudge

Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”

CIOMS Welcomes Draft Report Feedback On The Inevitable Future Of AI In Pharmacovigilance

 
• By Urtė Fultinavičiūtė

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

Viatris Pens Aprepitant Settlement Agreement After Kabi Loses Initial Patent Case

 
• By Dean Rudge

Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.