February 13, 2026
1 min read
Key takeaways:
Table of Contents
- Samsung Bioepis can launch Opuviz in the U.S. in January 2027.
- Opuviz, a biosimilar to Eylea, received FDA approval in 2024.
Under the terms of a settlement and license agreement with Regeneron, Samsung Bioepis will be able to launch Opuviz in the U.S. in January 2027, according to a press release.
“As with ranibizumab biosimilars, aflibercept biosimilars have the potential to significantly improve accessibility and affordability for patients,” Thomas Newcomer, vice president and head of U.S. commercial operations at Samsung Bioepis, told Healio. “As demand for treatment continues to grow, biosimilars can help manage costs with confidence without compromising on clinical standards.”
Opuviz (aflibercept-yszy 2 mg, Samsung Bioepis), a biosimilar to Eylea (aflibercept 2 mg, Regeneron), received FDA approval in 2024, as Healio previously reported. Under the terms of a previously announced agreement, Opuviz launched in the U.K. in January, with plans to launch in the rest of Europe in April and the rest of the world, except Korea, in May.
The other terms of the settlement are confidential, the release said.
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Disclosures:
Newcomer reports being vice president and head of U.S. commercial operations at Samsung Bioepis.
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