Opuviz is latest EC-approved ophthalmology biosimilar

18 November 2024

Following US approval in May this year, South Korea’s Samsung Bioepis and US biotech Biogen (Nasdaq: BIIB) have now won approval from the European Commission (EC) for their Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing Regeneron (Nasdaq: REGN) and Bayer’s (BAYN: DE) Eylea (aflibercept).

Opuviz, also known as SB15, is approved in adult patients for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

“Retinal disorders are affecting millions of people’s lives in Europe, yet many patients face barriers to treatment due to high costs,” said Byoungin Jung, vice president, regulatory affairs at Samsung Bioepis, which developed the biosimilar.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK