Harrow enters into agreement with Samsung Bioe for commercial rights to its ophthalmology biosimilar portfolio

Samsung Bioepis and Harrow have entered into a license, development, and commercialization agreement (DCA). In the agreement, Harrow will secure the exclusive US commercial rights to the ophthalmology biosimilar portfolio of Samsung Bioepis—ranibizumab-nuna 0.05 mL injection (BYOOVIZ), an FDA-approved biosimilar referencing LUCENTIS (ranibizumab), and aflibercept-yszy 0.05 mL injection (OPUVIZ), an FDA-approved biosimilar referencing EYLEA (aflibercept).

The commercial license will become effective upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis, which is expected to be completed by the end of 2025, according to Samsung Bioepis.

Previously, BYOOVIZ was commercialized by Biogen in the US since its initial launch in June 2022. However, in October 2024, Biogen notified Samsung Bioepis of its decision to terminate the 2019 Development and Commercialization Agreement within the US and Canada.

BYOOVIZ was approved by the US Food and Drug Administration (FDA) in September 2021 as the first ophthalmology biosimilar in the US 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). While OPUVIZ was approved in May 2024 for the treatment of patients with wet AMD, macular edema following RVO, diabetic macular edema (DME), and diabetic retinopathy (DR).

Josh Sang Hyun Lee, vice president and business development team leader at Samsung Bioepis, commented on the new partnership in a press release from the company,¹ saying, “We are pleased to partner with Harrow, a leading eye care 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.”

Mark L Baum, chairman and CEO of Harrow, also commented on the partnership, saying,² “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 US physicians and patients.”

Harrow noted that its acquisition of these products has the potential to “substantially lower the financial burden on Medicare and commercial plans, while improving access and affordability for patients.” The company states this is due to current anti-VEGF therapies being among the most expensive drug categories covered under Medicare Part B, with annual spending in the US exceeding $4.2 billion.²

Recently, Harrow acquired the exclusive US commercial rights to clobetasol propionate ophthalmic suspension 0.05% (BYQLOVI) from Formosa Pharmaceuticals. With the new deal with Harrow, Formosa terminated the existing agreement with Eyenovia due to “suspended sales of BYQLOVI due to corporate setbacks related to other programs.”

Harrow expects BYQLOVI to be commercially available in the fourth quarter of 2025.

References:

1. Samsung Bioepis Enters into a Partnership with Harrow for Commercialization of Ophthalmology Biosimilars Portfolio in the United States. Published July 17, 2025. Accessed July 17, 2025. https://www.businesswire.com/news/home/20250717437977/en/Samsung-Bioepis-Enters-into-a-Partnership-with-Harrow-for-Commercialization-of-Ophthalmology-Biosimilars-Portfolio-in-the-United-States

2. Harrow Enters into Commercialization Agreement with Samsung Bioepis for Ophthalmology Biosimilars Portfolio in the United States. Published July 17, 2025. Accessed July 17, 2025. https://investors.harrow.com/news-releases/news-release-details/harrow-enters-commercialization-agreement-samsung-bioepis

3. Harp MD. Formosa Pharmaceuticals grants Harrow commercial rights in US to clobetasol propionate ophthalmic suspension 0.05% (BYQLOVI), terminates deal with Eyenovia. Published June 12, 2025. Accessed July 17, 2025. https://www.ophthalmologytimes.com/view/formosa-pharmaceuticals-grants-harrow-us-commercial-rights-to-clobetasol-propionate-ophthalmic-suspension-0-05-byqlovi-terminates-deal-with-eyenovia