Harrow Secures Exclusive U.S. Commercial Rights to Samsung Bioepis' Ophthalmology Biosimilars Portfolio

Harrow, a North American eyecare pharmaceutical company, has entered into a commercialization agreement with Samsung Bioepis for its ophthalmology biosimilars portfolio in the US. The deal includes exclusive US commercial rights to BYOOVIZ (ranibizumab-nuna) and OPUVIZ (aflibercept-yszy), two widely used anti-VEGF therapies for retinal diseases. Harrow will assume full responsibility for commercialization upon completion of the transition from Biogen, expected by the end of 2025. The acquisition enhances Harrow's position as a leading ophthalmic pharmaceuticals provider and expands its pipeline with high-value biosimilars for sight-threatening retinal diseases.

Harrow Inc. (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, has entered into a commercialization agreement with Samsung Bioepis Co. Ltd. to secure exclusive US commercial rights to Samsung Bioepis' ophthalmology biosimilar portfolio. This includes BYOOVIZ® (ranibizumab-nuna) and OPUVIZ™ (aflibercept-yszy), two widely used anti-VEGF therapies for retinal diseases [1].

The agreement, announced on July 17, 2025, will see Harrow assume full commercial responsibility for these biosimilars by the end of 2025. This transition is expected to be completed after the termination of Biogen's 2019 Development and Commercialization Agreement with Samsung Bioepis in the US and Canada [1].

The acquisition enhances Harrow's position as a leading full-spectrum ophthalmic pharmaceuticals provider in the US. It also expands Harrow's pipeline with high-value biosimilars for sight-threatening retinal diseases, reinforcing its commitment to delivering value-oriented innovation to the US eyecare market [1].

BYOOVIZ is an FDA-approved biosimilar referencing LUCENTIS (ranibizumab), indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). OPUVIZ, an FDA-approved biosimilar referencing EYLEA (aflibercept), is indicated for the treatment of patients with Wet AMD, Macular Edema following RVO, Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR) [1].

The market opportunity for retinal disease treatment in the US is significant, with biosimilars expected to expand patient access and affordability. Harrow will leverage its established commercial infrastructure and national reach to accelerate the market impact of these biosimilars [1].

The acquisition has the potential to substantially lower the financial burden on Medicare and commercial plans, while improving access and affordability for patients. Current anti-VEGF therapies are among the most expensive drug categories covered under Medicare Part B, with annual spending in the US exceeding $4.2 billion [1].

Harrow is committed to reshaping the Wet AMD treatment landscape by offering an FDA-approved, on-label, and affordable alternative to existing anti-VEGF therapies. The company is excited to leverage its growing commercial presence within the retina specialist community and partner with Samsung Bioepis, known for its scientific excellence in biologics and biosimilars [1].

References:
[1] Harrow, Inc. (2025). Harrow enters into commercialization agreement with Samsung Bioepis for US ophthalmology biosimilars. Business Wire. Retrieved from https://www.businesswire.com/news/home/20250717236374/en/