U.S. commercialization rights for 'Byooviz' and 'Opuviz', both FDA-approved, to transfer by end of this year
Samsung Bioepis announced on July 18 that it has signed a partnership agreement with Harrow, a U.S.-based company, regarding the commercialization of two ophthalmology treatments in the United States.
This agreement concerns the U.S. commercialization of 'Byooviz®' (a Lucentis biosimilar, active ingredient ranibizumab, marketed as Amelivu® in Korea) and 'Opuviz™' (an Eylea biosimilar, active ingredient aflibercept, marketed as Afilivu® in Korea), both developed by Samsung Bioepis. The U.S. rights to these two products, which have been held by Biogen, will be transferred to Samsung Bioepis at the end of this year, at which point the agreement will take effect. Biogen will continue to handle sales of the products in the U.S. until the rights are transferred, after which Harrow will be responsible for sales in the U.S. market.
In October 2024, Biogen announced its intention to terminate the North American commercialization partnership for the two ophthalmology treatments that it had signed with Samsung Bioepis in 2019. Since then, the two companies have been carrying out the process of transferring the rights in the relevant territories.
Byooviz became the first Lucentis biosimilar to receive FDA approval in September 2021. It is prescribed for wet age-related macular degeneration and macular edema following retinal vein occlusion, and has been available in the U.S. market since June 2022. Opuviz received FDA approval in May 2024 and is indicated for wet age-related macular degeneration and diabetic macular edema.
Lee Sanghyun, Head of Business Development at Samsung Bioepis, stated, "Through this agreement with Harrow, which has strong sales capabilities in the North American ophthalmology treatment market, we will work closely with our partners to ensure a smooth transition of commercialization rights in the U.S. market." He added, "We will continue our efforts to expand patient access to high-quality biopharmaceuticals worldwide."
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