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

Celltrion Calls For Harmonized Approach To ‘Biobetters’

As Latest Data Shows Benefits Of Subcutaneous Infliximab Biosimilar Remsima SC

Executive Summary

A standardized, globally-accepted approach to ‘biobetters’ – biosimilars that offer improvements over the original reference drug – is needed to reduce trial duplication and allow products to come to market more quickly, Celltrion tells Generics Bulletin, at the same time as the company published data showing the benefits of its Remsima SC unique subcutaneous formulation of infliximab.

You may also be interested in...



Celltrion Says New Data Prove Remsima SC Is A ‘Biobetter’

Celltrion says new data show that its Remsima SC subcutaneous infliximab biosimilar produces “statistically greater improvements in clinical outcomes” for rheumatoid arthritis patients compared to intravenous infliximab.

Oral Humira Biosimilar Could Be A Game-Changer, Says Rani CEO

Oral delivery of biosimilars could bring significant benefits for patients as well as offering a key differentiating factor for competing developers, especially in the US adalimumab arena, Rani Therapeutics CEO Talat Imran tells Generics Bulletin.

Extra Indications Approved For Celltrion’s Remsima SC

The European Commission has granted an extension to Celltrion’s pan-European marketing authorization for subcutaneous biosimilar infliximab, which now covers indications for IBD and ankylosing spondylitis.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

GB151710

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