Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


EU Acceptance Of Foreign Comparators For Biosimilar Applications Will Boost Industry

This article was originally published in The Pink Sheet Daily

Executive Summary

The European Union has announced that it will accept a reference product for a biosimilar application from countries with robust regulatory systems and similar guidelines, a move that should significantly boost the domestic biosimilars industry.

You may also be interested in...

Europe’s Revised Biosimilars Guideline Allows Non-EU Data In Applications

Some data from a non-European version of a reference product can be used in biosimilar marketing applications, a revised overarching biosimilars guideline from European regulators says. It also notes interchangeability is a matter for individual European countries to decide.

Biosimilars’ Next Hurdle In EU Is Physician Opposition To Extrapolation

As Europe gears up to approve and publish a global development plan for biosimilars, doctors’ reluctance to support extrapolation of indications for these drugs could be costly stumbling block for industry.

Biosimilars Development In EU Could Get Easier; EC Mulls Accepting Outside Data

Industry applauds a suggestion by a senior healthcare representative that the European Commission could re-examine the overarching guideline on biosimilars to promote global development, but growth ultimately will be determined by greater worldwide harmonization.

Related Content


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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