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

Biosimilar Global Reference Standard Intrigues US FDA, But Many Questions Still To Answer

 
• By Derrick Gingery

Scientific and legal issues still must be resolved before establishing single reference products for biosimilar development, US FDA official says.

Twin girls are exercising on a lake shore, sprinkling water.

US and European regulators may like the idea of creating a global reference standard for biosimilars, but believe legal and other issues associated with it likely mean the idea is years away from being implemented.

A global reference standard would set one approved version of an innovator product as the basis for a biosimilar's development. The intent is to eliminate the need to mandate bridging...

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

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.

Fresenius Adds To Denosumab Competitors In Europe

 
• By Dave Wallace

At a busy meeting of the CHMP, the EMA issued positive opinions for Fresenius Kabi’s denosumab rivals to Prolia and Xgeva, another denosumab biosimilar from Sandoz, a Tecfidera hybrid from Neuraxpharm and a Descovy generic from Viatris. Meanwhile, Ascend has withdrawn a teriparatide filing.

Alvotech And Advanz Add Three More In €160m EU Partnership Expansion

 
• By Dean Rudge

Fresh from filing a proposed biosimilar to Xolair (omalizumab) in the UK, Alvotech and Advanz have shaken hands on a further deal to expand their partnership.

Abiogen And mAbxience Join Forces In Italy

 
• By Dave Wallace

Spanish biosimilars developer mAbxience has struck a deal with Italy’s Abiogen covering an undisclosed biosimilar for the Italian market.

More from Products

Abiogen And mAbxience Join Forces In Italy

 
• By Dave Wallace

Spanish biosimilars developer mAbxience has struck a deal with Italy’s Abiogen covering an undisclosed biosimilar for the Italian market.

Teva Brings In European Trastuzumab With Prestige BioPharma Agreement

 
• By Dean Rudge

Teva will now market biosimilar Herceptin in both the US and Europe, after penning an agreement with Singaporean firm Prestige BioPharma for its Tuznue rival to the monoclonal antibody to treat HER2-positive breast cancer and HER2-positive metastatic stomach cancer.

SteinCares Deal Leads Lupin’s Ranibizumab Into Latin America

 
• By Dave Wallace

Lupin is planning to make inroads into the Latin American biosimilars market through a deal with local player SteinCares for a ranibizumab rival to Lucentis.