Samsung Bioepis Partners with Harrow to Market Ophthalmology Biosimilars in the US

Samsung Bioepis Co., Ltd., headquartered in Incheon, Korea, has announced a new strategic collaboration with Harrow, a prominent player in the ophthalmic pharmaceutical industry. This partnership centers around the license, development, and commercialization of Samsung Bioepis' ophthalmology biosimilars, BYOOVIZ® (ranibizumab-nuna) and OPUVIZ™ (aflibercept-yszy), for the U.S. market. These products are biosimilar versions of LUCENTIS (ranibizumab) and EYLEA (aflibercept), respectively.

The agreement stipulates that the commercial rights will fully transfer from Biogen to Samsung Bioepis by the end of 2025, a process that is already in motion. Once this transfer is finalized, Harrow will assume complete responsibility for marketing and selling BYOOVIZ and OPUVIZ in the United States.

This development follows Biogen's decision in October 2024 to terminate its 2019 Development and Commercialization Agreement with Samsung Bioepis for the U.S. and Canadian markets. As part of this transition, Samsung Bioepis has been collaborating closely with Biogen to ensure a smooth handover of commercialization rights for the two biosimilars.

BYOOVIZ has been available in the U.S. market since June 2022, following its FDA approval in September 2021. It is approved for treating conditions such as Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). Meanwhile, OPUVIZ received FDA approval in May 2024. It is indicated for Wet AMD, Macular Edema following RVO, as well as Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR).

Josh Sang Hyun Lee, Vice President and Business Development Team Leader at Samsung Bioepis, expressed enthusiasm about the partnership with Harrow. He emphasized the importance of ensuring a seamless transition and continued service delivery to U.S. customers during this handover phase. Lee also reiterated Samsung Bioepis’ commitment to expanding access to affordable, high-quality biologic medicines globally.

BYOOVIZ, an intravitreal injection of ranibizumab-nuna, is a vascular endothelial growth factor (VEGF) inhibitor. It is primarily used to manage serious eye conditions like Neovascular AMD, Macular Edema following RVO, and mCNV. However, patients should be aware of potential side effects, including endophthalmitis, retinal detachment, and increased intraocular pressure. The most frequently reported adverse reactions include conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure.

OPUVIZ, an intravitreal injection of aflibercept-yszy, also functions as a VEGF inhibitor. Its indications mirror those of BYOOVIZ, with additional approval for DME and DR. Safety precautions similar to those for BYOOVIZ apply, with patients advised to monitor for potential complications such as retinal detachments and increases in intraocular pressure. Common adverse reactions noted in patients receiving aflibercept include conjunctival hemorrhage, eye pain, cataracts, vitreous detachment, and increased intraocular pressure.

Founded in 2012, Samsung Bioepis is devoted to making healthcare accessible through innovation and quality. The company is advancing a diverse pipeline of biosimilar candidates across various therapeutic areas, including ophthalmology, immunology, and oncology. Samsung Bioepis aspires to be a global leader in the biopharmaceutical industry.