
Samsung Bioepis has signed a licensing agreement with US-based pharmaceutical firm Harrow for the development and commercialisation its ophthalmology biosimilars portfolio in the US.
The portfolio includes Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab), and Opuviz (aflibercept-yszy), referencing Eylea (aflibercept).
Lucentis is offered by Swiss pharmaceutical company Novartis, while Eylea is provided by Regeneron and Bayer.
In October 2024, Samsung Bioepis and US-based biotechnology firm Biogen ended their 2019 development and commercialisation agreement for the US and Canada.
Samsung Bioepis has been working with Biogen to transfer the rights to commercialise Byooviz and Opuviz back to Samsung Bioepis in these regions.
The transition of commercial rights from Biogen to Samsung Bioepis is anticipated to conclude by the end of 2025.
Following the completion of the commercial licence transfer, Harrow will take full responsibility for the commercialisation of Byooviz and Opuviz in the US.
Samsung Bioepis vice president and business development team leader Josh Sang Hyun Lee said: “We are pleased to partner with Harrow, a leading eyecare pharmaceutical company with strong capabilities in commercialization of ophthalmic pharmaceutical products in the North American market.
“We will work closely with both Biogen and Harrow to ensure a seamless transition and the continued delivery of services to our customers and patients in the US market.
“Samsung Bioepis remains committed to expanding access and widening treatment options for healthcare systems, healthcare professionals, and patients, by providing affordable and high-quality biologic medicines around the world.”
Byooviz received the US Food and Drug Administration (FDA) approval in September 2021 as the first biosimilar for Neovascular (Wet) Age-Related Macular Degeneration (AMD).
The indication also includes Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV).
Byooviz has been available in the US market since June 2022.
Opuviz was approved in May last year, for the treatment of Wet AMD, Macular Edema following RVO, Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).
Earlier this year, Samsung Bioepis also partnered with Israeli company Teva Pharmaceutical to license, develop, and commercialise Epysqli (eculizumab-aagh) in the US.
Epysqli is a biosimilar to Alexion’s Soliris (eculizumab), a treatment for rare diseases.
Under the terms of the agreement, Samsung Bioepis is responsible for the development, regulatory registration, manufacture, and supply of the product.