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

Cimerli Interchangeable Biosimilar Approved Without Switching Data

Coherus Ranibizumab Rival Will Compete With Lucentis And Byooviz In US

Executive Summary

Citing low risk of a clinically impactful immunogenic response from systemic anti-drug antibodies and intraocular inflammation when alternating between Coherus’ Cimerli and Genentech’s reference product ranibizumab, US FDA says a switching study would not be informative.

You may also be interested in...



Coherus Shrugs Off Missing Ranibizumab Pre-Filled Syringe – For Now

Coherus BioSciences had much to say during its second-quarter earnings call in the wake of USFDA approval for its Bioeq-partnered Cimerli biosimilar to Roche’s Lucentis.

Samsung Bioepis Goes After Lucentis With 40% Cheaper Byooviz Launch In US

Samsung Bioepis and Biogen have come in with a hefty discount as they mark a major milestone by launching their Byooviz biosimilar ranibizumab rival to Lucentis in the US.

First Interchangeable Humira Biosimilar Approved In US

Boehringer Ingelheim has won a landmark first US interchangeability designation for a biosimilar to Humira, with the firm’s Cyltezo version of adalimumab representing the second ever interchangeable biosimilar approved by the FDA.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

GB152070

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