1. Generics Bulletin
  3. >>Biosimilars

Provisionally Interchangeable? FDA Weighs ‘Requirements’ For Pfizer’s Adalimumab

FDA-Approved Abrilada ‘Meets The Standards As An Interchangeable Biosimilar’

 
• By Dean Rudge

Pfizer has responded to Generics Bulletin’s queries regarding its bid to win an interchangeability designation for its Abrilada (adalimumab-afzb) biosimilar to AbbVie’s Humira reference product.

Question mark made by white pills spilling out of brown bottle on pink background. Creative medicine for health/medical problem, medication error, drug information and pharmacy concept. Copy space.
• Source: Shutterstock

With biosimilar interchangeability in the US in its infancy, Pfizer Inc. appears to have been caught in the controversial designation’s evolving and somewhat indeterminate landscape, in its bid to win interchangeability for the firm’s already approved Abrilada (adalimumab-afzb) biosimilar.

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 Biosimilars

More from Products

Samsung Rolls Out Second US Soliris Biosimilar – At 30% WAC Discount

 
• By Dean Rudge

Samsung Bioepis and Teva have provided clarity on the pricing of their Epysqli biosimilar to Soliris in the US, as the firms launched only the second rival to the rare diseases treatment.

Biosimilars Industry Buoyed By EMA Paper On Reducing Clinical Trials

 
• By Dave Wallace

The EMA’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam. Generics Bulletin discusses the new draft reflection paper and its significance for industry, reports on reactions from the event, and reveals the next steps unveiled by EMA officials.

Meitheal Adds To US Liraglutide List As It Looks To Ease Shortage Concerns

 
• By Dean Rudge

Meitheal Pharmaceuticals said that its generic version of the GLP-1 agonist Victoza would be one of 22 planned launches during 2025, as the firm continues to build out its portfolio with the aid of its parent, Hong Kong King-Friend Industrial.