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

Sorrento’s Partner Mabpharm Files For Infliximab In China

Sorrento Plans US Filing For Infliximab ‘Biobetter’ In 2020

Executive Summary

Banking on the burgeoning biosimilars approvals in China, Sorrento’s partner Mabpharm has filed in China for an infliximab biosimilar. Sorrento plans to follow this up with a US filing for a ‘biobetter’ version via the BLA route in 2020.

You may also be interested in...



Celltrion Pushes ‘Biobetters’ Concept With Remsima SC

Celltrion head of clinical development Sang Joon Lee has set out the promise of ‘biobetters’ – biosimilars that improve upon the original reference product – at the FT Global Pharmaceutical and Biotechnology Conference 2019. However, obstacles remain, including the lack of a tailored regulatory pathway.

Bio-Thera Solutions Has China’s First Adalimumab Biosimilar

Bio-Thera Solutions has secured only the second biosimilar approval ever from China’s NMPA, and the country’s first biosimilar approval for a rival to Humira (adalimumab).

Chinese Biosimilar Boom Is Heralded By First Approval

Approval of China's first rituximab biosimilar under new pathway gives developers much-needed boost and an opening to the international market for made-in-China biosimilars helped by favorable regulatory policy changes at home.

Topics

Related Companies

UsernamePublicRestriction

Register

GB149501

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