3. >>Regulation

EMA Validates Henlius’ Pertuzumab Biosimilar Application

The Milestone Adds Another Major Market To The Company’s Tally

 
• By Adam Zamecnik

The EMA has accepted for review Henlius’ Perjeta biosimilar, which is to be commercialized by the Chinese company’s global partner Organon in the EU.

man holding capsules in front of complete wavy national flag of Europe symbolizing health, medicine
(Shutterstock)

The European Medicines Agency has accepted for review Organon’s application for its Henlius-partnered Perjeta (pertuzumab) biosimilar, paving the way for approval in a major global market.

The Perjeta biosimilar was the subject of a $100m+ deal between Organon and the Chinese company Shanghai Henlius Biotech signed...

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 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.