Pink Sheet 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

EU Biosimilar Filings, Opinions And Approvals

Executive Summary

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.

You may also be interested in...



EMA Addresses Need For Guideline On Antivirals & MAbs For COVID-19

New EU guidance will cover non-clinical and clinical development, trial design, endpoints, safety issues and comparators, as well as the use of immunobridging studies.

French Agency Sets Up New Body To Advise On Biosimilar Substitution

The new committee, which will initially be in place for a year, will advise the French drug regulator when it is preparing its opinions on substitution in specific biosimilar product groups.

Australia Gears Up For More Action On Drug Shortages

The TGA has taken a series of actions to address supply chain issues, including on the regulatory front, but it says more remains to be done and is asking stakeholders for suggestions in a new online survey.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS146235

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