1. Generics Bulletin
  2. >>Policy & Regulation
  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

Regulatory Recap: EU Pharma Package Progresses Forward With Extended Data Protection

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

US ‘Red Tape’ Bill Again Targets Biosimilar Interchangeability – Will It Succeed This Time?

 
• By Dave Wallace

After multiple past attempts, US legislators have once again proposed a bill that would make all biosimilars immediately interchangeable upon approval. Could a fresh political context help it to succeed this time?

Sandoz Scores Regional First With EU Launch Of Autoinjectable Stelara Rival

 
• By Adam Zamecnik

Doubling down on the launch of its Stelara biosimilar Pyzchiva in Europe last year, Sandoz has just released an autoinjectable version of the drug, with the aim to offer a more convenient option for ustekinumab patients.

More from Generics Bulletin

Regulatory Recap: EU Pharma Package Progresses Forward With Extended Data Protection

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.

Regeneron Monitoring Eylea Biosimilar Closely Following Innovative Setbacks

 
• By Dean Rudge

Regeneron says it is closely watching Amgen’s Pavblu 2mg aflibercept biosimilar, which is gaining traction via financial incentives to physicians as “the only differentiator” to its Eylea reference brand. Meanwhile, Regeneron is aiming to boost Eylea HD uptake amid regulatory setbacks.

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.