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

EMA ‘Yes’ For Pegfilgrastim Biosimilars Spells End For Neulasta’s EU Stronghold

Executive Summary

Approval of the first pegfilgrastim biosimilars in the EU would mark the start of a period of accelerated sales declines for Amgen's Neulasta but the outlook for the blockbuster bio-originator is not necessarily bleak.

You may also be interested in...



EU First For Pegfilgrastim Biosimilars? EMA Decides This Week

Two biosimilar versions of Amgen’s blockbuster drug, Neulasta, are up for an opinion from the European Medicines Agency this week on whether they should be approved in the EU. Coherus is the sponsor of one of the products.

Mylan Is First To Clear US Neulasta Biosimilar Hurdle; At-Risk Launch May Not Be Risky

Fulphila (pegfilgrastim-jmbd) to launch in US soon; Mylan overcomes complete response letter and gets approval without advisory committee review.

Apotex Bags First Biosimilar Neulasta, Plans To Undercut Amgen In Canada By 25%

Apotex is hoping to sell its biosimilar version of Amgen’s Neulasta at a 25% discount in Canada after gaining approval there in what seems to be a world first. Might the Canadian OK help unblock the path to approval in the US and the EU?

Topics

Related Companies

UsernamePublicRestriction

Register

GB001849

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