Harrow Secures U.S. Rights to Samsung Bioepis Eye Biosimilars

Harrow has announced a definitive commercialization agreement with Samsung Bioepis, granting Harrow the exclusive U.S. commercial rights to Samsung Bioepis’ ophthalmology biosimilars portfolio. This strategic move includes Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab), and Opuviz (aflibercept-yszy), a biosimilar to Eylea (aflibercept)—both of which are FDA-approved and indicated for the treatment of serious retinal diseases.

Transition of Commercial Rights from Biogen to Harrow

Byooviz was first launched in the U.S. in June 2022 under the commercial leadership of Biogen. In October 2024, Biogen notified Samsung Bioepis of its intent to terminate the 2019 Development and Commercialization Agreement covering the U.S. and Canada. Since then, Samsung Bioepis has been working closely with Biogen to transition the commercial rights for Byooviz and Opuviz back to its own control in these territories.

Under the new agreement, Harrow will take full responsibility for the commercialization of Byooviz in the U.S. once the transition from Biogen to Samsung Bioepis is complete. This transition is expected to be completed by the end of 2025.

Expanding Harrow’s Retina-Focused Portfolio

According to Harrow, the acquisition of these high-value ophthalmic biosimilars significantly strengthens its position as a full-spectrum ophthalmic pharmaceuticals provider in the U.S. The agreement broadens Harrow’s footprint in the retina treatment space, offering FDA-approved alternatives for wet age-related macular degeneration (AMD), retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (CNV).

Leadership Commentary on Strategic Impact

“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,” said Mark L. Baum, Chairman and CEO of Harrow, in a company news release.

He added, “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.”

Product Profiles: Byooviz and Opuviz

Byooviz (ranibizumab-nuna) is the first FDA-approved biosimilar to Lucentis. It is 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 (aflibercept-yszy) is an FDA-approved biosimilar to Eylea, indicated for the treatment of wet AMD, RVO, diabetic macular edema (DME), and diabetic retinopathy (DR).