Generics Bulletin 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

UsernamePublicRestriction

Biosimilars Get Bespoke Service: EMA To Pilot Tailored Scientific Advice

Executive Summary

Quality data will be focus of ‘extra advice’ offered by European Medicines Agency’s pilot, which will suggest directions for sponsors’ next steps but stop short of formal data evaluation.

You may also be interested in...



Blockbuster Competitors Figure Large Among Biosimilars Under Review in EU

Amgen’s first biosimilar – a competitor to AbbVie’s Humira – and three would-be competitors to Amgen’s own Neulasta are among the 17 biosimilar products that are under evaluation at the European Medicines Agency.

Biosimilars Will Get PDUFA-Style Reviews Under New User Fee Plan

FDA will have a total of 12 months to review 351(k) applications and additional time to schedule certain product development meetings under the Biosimilar User Fee Act II agreement; measures to enhance management of user fee resources and improve hiring will carry over from PDUFA VI.

BeiGene’s Brukinsa Among Nine Drugs To Win EU Marketing Thumbs Up

A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval. 

Topics

UsernamePublicRestriction

Register

GB001918

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