1. Generics Bulletin
  2. >>Policy & Regulation

Sandoz's Multi-Switch Biosimilar Trials: A View To Interchangeability?

 
• By Derrick Gingery

Company's application development seems to be outpacing FDA's policy development in next step along the 351(k) pathway.

SandozNorvatisDiv_1200

Sandoz Inc.'s application package for its biosimilar to Amgen Inc.'s Enbrel continues to signal to FDA that the company is ready to move forward on interchangeability even if the agency is not.

A clinical study with multiple switches between GP2015 and its reference product was part of Sandoz's application to determine it...

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 Policy & Regulation

More from Generics Bulletin

Celltrion Reinforces Commitment To UK Biosimilars Market With New HQ

 
• By Dave Wallace

Celltrion has reinforced its commitment to the UK by opening a new central operations hub in Uxbridge, while acknowledging that “major questions over the attractiveness of the market” need to be addressed to encourage development and ensure a sustainable environment for UK biosimilars.

‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
• By Dean Rudge

England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.

Tevogen Will House Generics Unit In Much-Expanded New Headquarters

 
• By Dean Rudge

Tevogen is looking to accelerate its growth with a major expansion of its headquarters in Warren, New Jersey, more than doubling its footprint to centralize research and development, regulatory, and corporate functions. The new facility will support the company’s evolving initiatives.