1. Pink Sheet
  2. >>Product Reviews
  3. >>Approvals

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Concept of national healthcare system - EU - European Union
A second biosimilar version of golimumab has been filed for regulatory review in the EU • Source: Shutterstock

The table below shows EU regulatory developments in the biosimilars area since 2018. It covers new product filings with the European Medicines Agency, opinions from the EMA’s drug evaluation committee, the CHMP, withdrawals of marketing authorization applications (MAAs), and decisions on biosimilar marketing authorizations by the European Commission.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Approvals

Semaglutide For MASH Among Raft Of New EU Filings

 
• By Neena Brizmohun

Novo Nordisk’s application seeking EU marketing approval to use its GLP-1 receptor agonist to treat cirrhotic metabolic dysfunction-associated steatohepatitis is one of 15 new drug filings the European Medicines Agency has started reviewing. Meanwhile, Arrowhead’s filing for its familial chylomicronemia syndrome, plozasiran, is being fast tracked.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.

Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

 
• By Neena Brizmohun

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

More from Geography

Brazil’s ANVISA Clarifies Registration Procedures For Biologicals

 
• By Francesca Bruce

Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.

SpringWorks To Make Its Case For Nirogacestat At High-Stakes EMA Meeting

 
• By Francesca Bruce

Nirogacestat was one of four products scheduled for an oral explanation meeting at the European Medicines Agency this week.

Postmarketing Surprise Is Latest Plot Twist For Novavax’s COVID-19 Vaccine BLA

 
• By Bridget Silverman

Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.