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

Samsung Bioepis First To File EU Lucentis Rival

Confirms SB11 Ranibizumab Biosimilar Candidate Accepted For Filing By EMA

Executive Summary

Samsung Bioepis has beaten its rivals to become the first firm to announce successful filing of a ranibizumab biosimilar rival to Lucentis in the EU.

You may also be interested in...



Samsung Bioepis Begins Denosumab Trials

Samsung Bioepis has announced that its Prolia/Xgeva (denosumab) biosimilar, SB16, has begun Phase I clinical trials. Further, the company’s Lucentis (ranibizumab) biosimilar, SB11, has produced positive Phase III data and has been filed in the US. Meanwhile, CEO and president Christopher Hansung Ko has commented on the impact of the coronavirus pandemic on the industry and competition from domestic companies in the Chinese market. 

Bluebird’s Eli-Cel Gene Therapy Among Myriad New Drugs Seeking EU Approval

An advanced immunotherapy for recurrent glioblastoma and the first biosimilar version of Lucentis for age-related macular degeneration have also been submitted for review by the European Medicines Agency for potential pan-EU authorization.

Xbrane To File Ranibizumab Biosimilar In Europe And US Within 12 Months

Sweden’s Xbrane is aiming to file for approval of its Xlucane (ranibizumab) biosimilar to Lucentis in Europe and the US, and license the rights for the product’s sale and marketing of in Latin America, Japan and China, in the next 12 months.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1134531

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