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
UsernamePublicRestriction

Mylan And Lupin Get EU Etanercept Nod

European Commission's Final Decision On Biosimilar Approval Due By May

Executive Summary

Mylan, in partnership with Indian firm Lupin, will be looking to rival Biogen and Sandoz by introducing an etanercept biosimilar in European markets following a positive opinion by the EMA’s CHMP on Mylan's application.

You may also be interested in...



Mylan And Lupin Prepare To Launch EU Etanercept

Mylan and Lupin have revealed when they expect to launch their etanercept biosimilar, Nepexto, in Europe after receiving formal European Commission approval.

Mylan Is Only Just Beginning Its Biosimilars Journey

Despite having biosimilars of insulin glargine and etanercept that are expected to launch in the US and Europe respectively midway through this year, a biosimilar bevacizumab candidate filed in both regions, an in-development Botox rival still being considered and several other biosimilars already on the market around the world, Mylan insists that its biosimilars journey is just beginning.

String Of Positives Lifts Lupin's Outlook

Tentative FDA approval for Lupin’s arformoterol tartrate inhalation solution and a potential European nod for etanercept are seen aiding the company’s prospects in FY2021. Besides, success in a Phase III trial for secnidazole to treat trichomoniasis bodes well, though manufacturing clearances and continuity will also be closely watched.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

SC066183

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

Cancel