Samsung Bioepis gets nod for sale of ophthalmology biosimilar in Europe

South Korea’s biopharmaceutical company Samsung Bioepis Co. won approval from European authorities for sale of Byooviz, its ophthalmology biosimilar of Lucentis, expanding its product portfolio, which has been focusing on existing autoimmune disease treatments.

Samsung is the first company to be granted permission from the European Commission to sell Lucentis’ biosimilar.

The final permission came about two months after the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) recommended its approval in Europe in June, according to Samsung on Aug. 23.

Lucentis is a medication for ophthalmic disease and has indications for treating macular degeneration and diabetic macular edema. Roche and Novartis are selling the medicine developed by Genentech. The drug’s global sales were about $3.4 billion last year. Its US patent expired in June of last year, while its European patent is scheduled to end in July of next year.

Since November of last year, the US Food and Drug Administration (FDA) has been reviewing Samsung’s application for permission to sell in the US. The authority is expected to make a final decision within this year at the earliest.

Samsung is also developing SB15, a biosimilar of Bayer and Regeneron’s ophthalmic disease treatment Eylea, which is currently in Phase 3 clinical trials. Eylea’s global revenue is about double that of Lucentis.

Samsung has been selling three autoimmune disease treatments and two anticancer drugs in overseas markets,  including the US and Europe, but it has not exported any eye disease treatment yet.

Write to Jae-young Han at jyhan@hankyung.com
Jongwoo Cheon edited this article.