Harrow Enters into Commercialization Agreement with Samsung Bioepis for Biosimilars Portfolio in the US

Harrow announced that it has entered into a definitive agreement with Samsung Bioepis to secure the exclusive US commercial rights to the ophthalmology biosimilar portfolio of Samsung Bioepis, which includes Byooviz (ranibizumab-nuna), an FDA-approved biosimilar referencing Lucentis (ranibizumab), and Opuviz (aflibercept-yszy), an FDA-approved biosimilar referencing Eylea (aflibercept).

Financial terms of the deal were not disclosed. 

Byooviz has been commercialized by Biogen in the US since its initial launch in June 2022. In October 2024, Biogen notified Samsung Bioepis of their decision to terminate the 2019 Development and Commercialization Agreement within the US and Canada. Samsung Bioepis has been closely working with Biogen on the transfer of commercialization rights for Byooviz and Opuviz back to Samsung Bioepis in these regions. Harrow will assume full responsibility for commercialization of Byooviz in the US upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis. The transition is expected to be completed by the end of 2025.

According to Harrow, the acquisition enhances its position as a full-spectrum ophthalmic pharmaceuticals provider in the US, expanding its pipeline with high-value biosimilars for sight‑threatening retinal diseases.

“This transformational acquisition marks a pivotal moment for Harrow and reinforces our commitment to delivering innovation, accessibility, and value to the U.S. ophthalmology community,” Mark L. Baum, Chairman and CEO of Harrow, said in a company news release. “We are excited to leverage our growing commercial presence within the retina specialist community, built over the past year, and partner with Samsung Bioepis, globally recognized for its scientific excellence in biologics and biosimilars. These ophthalmic assets are among the most highly regarded in the market, and we are looking forward to bringing these products to U.S. physicians and patients.”

Byooviz is the first FDA-approved Lucentis  biosimilar indicated for the treatment of patients with wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (CNV). Opuviz is an FDA-approved Eylea biosimilar indicated for the treatment of patients with wet AMD, RVO, diabetic macular edema (DME), and diabetic retinopathy (DR).