Samsung Bioepis announced on the 17th that it has entered into a partnership agreement with Harrow for the sale of ophthalmic disease treatments in the United States.
The agreement aims for the U.S. commercialization of two ophthalmic disease treatments developed by Samsung Bioepis: the Lucentis biosimilar "Byooviz" (active ingredient ranibizumab) and the Eylea biosimilar Opuviz (aflibercept).
Byooviz received the first product approval as a Lucentis biosimilar from the U.S. Food and Drug Administration (FDA) in September 2021. It is prescribed for wet age-related macular degeneration, retinal vein occlusion followed by macular edema, and has been supplied to the U.S. market since June 2022.
Opuviz received FDA product approval in May of last year and is applicable for wet age-related macular degeneration and diabetic macular edema.
Previously, Biogen held the North American rights for two ophthalmic disease treatments from 2019, but terminated its development and commercialization (DCA) agreement in October of last year.
The U.S. rights will be transferred from Biogen to Samsung Bioepis later this year, after which Harrow is expected to take over. Biogen will continue to manage product sales until the transfer of rights, and thereafter Harrow will be responsible for the U.S. market sales of those products.
Lee Sang-hyun, Head of Team for Business Development at Samsung Bioepis, noted, "Through this agreement with Harrow, which has high sales capabilities in the North American ophthalmic disease treatment market, we will closely cooperate with our partners to ensure a smooth transfer of rights in the U.S. market."