R&D Industry Finds Biosimilar Interchangeability Statement By EU Regulators ‘Concerning’

 
• By Francesca Bruce
  
Generate a summary of this article
Listen to this article
Beta

A joint statement from the European Medicines Agency and Heads of Medicines Agencies on biosimilar interchangeability is “concerning,” says Europe’s R&D-based industry federation, EFPIA.

Interchangeable
Biosimilars and reference products are interchangeable, say the EMA and HMA • Source: Shutterstock

A statement from the European Medicines Agency and the EU’s Heads of Medicines Agencies asserting that approved biosimilars and their reference products are interchangeable is concerning, says EFPIA, Europe’s R&D-based pharmaceutical industry lobby group. Although it will have no immediate impact, the statement could influence policies in the EU member states, which have different approaches when it comes to switching such products, say lawyers.

The statement, issued on 19 September, says that the EMA and the HMA “consider that once a biosimilar is approved...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Europe

EU Biosimilar Filings, Opinions And Approvals

 
• By Saba Afreen

<p>Executive Summary</p> <p>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.</p>

EU Pharma Reform: What You Need to Know Now

 
• By Anabel Costa-Ferreira and Ian Schofield

As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.

New EU Approvals

<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>

More from Geography

Canada Cuts Red Tape With Single Ethics Review For Trials

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

Nancy Test Circulable Section Geography

 
• By Brian Bossetta

This is a short description

Diversity Action Plans: What To Submit And When

 
• By Nielsen Hobbs

With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.