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

EU’s CHMP Expected To OK Another Biosimilar Humira

Executive Summary

The European Medicines Agency’s CHMP is expected to give the green light to Samsung Bioepis’ biosimilar version of AbbVie’s anti-TNF-alpha Humira on June 23. Numerous other biosimilar developers have biosimilar adalimumabs under development in a bid to break into the $16bn market for the world’s top-selling drug.

You may also be interested in...



Boehringer Ingelheim Limbering Up With Humira Biosimilar

Presenting equivalence data at EULAR for its biosimilar version of the world's best-selling drug, Humira, Boehringer Ingelheim is optimistic about its position in a crowded field. Karsten Kissel, head of global medical affairs biosimilars for the German group, spoke to Scrip.

Biosimilar Launches Depend Mostly On Patents After Supreme Court Ruling

US high court says biosimilar sponsors do not have to wait until after FDA approval to start countdown clock for marketing, but patent litigation may impede launches.

Sandoz Files Biosimilar Humira & Remicade In EU; 13 Products Now Under Evaluation By CHMP

Applications for biosimilar medicines are continuing to arrive at the European Medicines Agency, with Sandoz’s versions of AbbVie’s Humira and Janssen’s Remicade having just been accepted for filing. This brings to 13 the number of biosimilars under evaluation; seven more are awaiting a marketing authorization decision from the European Commission.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

GB001785

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