Sandoz and Regeneron settle aflibercept dispute, paving way for US debut
Sandoz (SIX: SDZ) has resolved all US patent litigation with Regeneron (Nasdaq: REGN) over its aflibercept biosimilar, Enzeevu (aflibercept). Under the deal, Sandoz can enter the US market in the fourth quarter of 2026, or earlier under certain conditions, removing a major hurdle to its ophthalmology push.
The settlement ends a case brought in 2024 under the Biologics Price Competition and Innovation Act. Enzeevu, approved by the US regulator in August 2024, matches the reference product’s dosage form, route, and presentation. The agency has also provisionally deemed Enzeevu interchangeable, with timing subject to existing first-interchangeable exclusivity.
Enzeevu is indicated to improve and maintain vision in neovascular age-related macular degeneration, a common cause of sight loss in people over 50. Aflibercept works by blocking VEGF-A and PlGF, proteins that drive abnormal blood vessel growth in the eye — a straightforward mechanism that helps keep the narrative easy to follow.
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.
Login to your accountTry before you buy
Free
7 day trial access
- 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
- 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
More on this story...
Today's issue
Company Spotlight
More Features in Biosimilars
| Headless Content Management with Blaze