Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

EMA-HMA Biosimilar Interchangeability Statement Offers ‘Unity And Clarity’ For Europe

Provides Foundation For Uptake Ahead Of Upcoming EU Pharmaceutical Legislation Reform

Executive Summary

The recent statement by the EMA and HMA affirming the interchangeability of biologics and biosimilars has given a boost to Europe’s biosimilars industry ahead of key legislative reforms, heard delegates to Medicines for Europe’s 18th Biosimilar Medicines Conference in Brussels.

You may also be interested in...



‘I Would Love To Have All The Biologic Assets’ – Formycon’s Glombitza Sets Out Portfolio Approach

In the second part of an exclusive interview, Formycon CEO Stefan Glombitza talks to Generics Bulletin about key regulatory developments in Europe and the US, the firm’s portfolio selection strategy, and upcoming milestones on the horizon.

EMA Mulls Dropping Comparative Efficacy Trials For Biosimilars

In a move that could hold major promise for the biosimilars industry, the European Medicines Agency has opened up a consultation on re-evaluating the need for comparative efficacy studies to support biosimilar applications.

All Biosimilars Interchangeable? FDA Backs Switching With Spotlight On Science

In meta-analyses of biosimilar switching studies, FDA researchers found ‘zero difference in the risk of death, serious adverse events, and treatment discontinuations between participants who switched between biosimilars and reference products and participants who did not switch.’

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

GB152213

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel