FDA approves Samsung Bioepis’ Opuviz

[Courtesy of Samsung Bioepis]

The U.S. Food and Drug Administration (FDA) has approved Samsung Bioepis’ Opuviz, a biosimilar to blockbuster ophthalmic drug Eylea, for the treatment of various eye diseases. This is first time an Eylea biosimilar has received FDA approval and the authority also approved Yesafili, a biosimilar developed by India’s Biocon Biologics, alongside Opuviz.

The approval, which was announced on Monday (local time), grants interchangeability status to both Opuviz and Yesafili, allowing pharmacies to substitute these biosimilars for Eylea without a physician’s approval. This designation is expected to reduce patient wait times, address drug shortages, and streamline access to biologic drugs.

Opuviz and Yesafili are vascular endothelial growth factor (VEGF) inhibitors, administered via intravitreal injection to treat conditions such as neovascular age-related macular degeneration (AMD), macular edema, and diabetic retinopathy. These conditions, if untreated, can lead to significant vision loss or blindness.

Eylea, originally developed by Regeneron and Bayer AG, recorded $9.21 billion in global sales in 2024, over half of which came from the U.S. market. Eylea works by inhibiting abnormal blood vessel growth and leakage under the retina, which can cause severe pain and vision impairment.

The global macular degeneration treatment market is expected to surge from $7.4 billion in 2021 to $27.5 billion by 2031. The FDA has approved 52 biosimilars to date, according to the Korea Biotechnology Industry Organization. Korean companies have received approval for 11 products, including six from Samsung Bioepis and five from Celltrion Inc.