Samsung Bioepis has signed a licensing agreement with U.S.-based ophthalmic pharmaceutical company Harrow for the commercialization rights of its biosimilar treatments for eye diseases in North America. Under the agreement, Harrow will be responsible for the sales and marketing of two ophthalmology biosimilars currently being developed by Samsung Bioepis. This marks a new partnership following the termination of its previous agreement with Biogen.
On July 17 (local time), Harrow announced that it had entered into a License, Development, and Commercialization Agreement (DCA) with Samsung Bioepis for the North American rights to two biosimilars: BYOOVIZ and OPUVIZ. Specific details of the agreement, including its duration and financial terms, were not disclosed.
Harrow will assume full commercial responsibility for both products once commercialization rights are fully transferred from Biogen to Samsung Bioepis by the end of this year. The deal is expected to boost Samsung Bioepis’s market share and revenue in the U.S. biosimilar sector.
BYOOVIZ, approved by the U.S. Food and Drug Administration (FDA) in September 2021, is the first ophthalmology biosimilar approved in the United States. It has been commercially available since June 2022 and is used to treat neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).
OPUVIZ was approved by the FDA in May 2024. It is indicated for the treatment of wet AMD, macular edema following RVO, diabetic macular edema (DME), and diabetic retinopathy (DR).
The new partnership follows the expiration of Samsung Bioepis’s previous licensing agreement with Biogen. In October 2023, Biogen notified Samsung Bioepis of the termination of their 2019 development and commercialization agreement covering the U.S. and Canadian markets. Since then, Samsung Bioepis has focused on ensuring a smooth transfer of commercialization rights.
This new alliance is expected to serve as a major stepping stone for the expanded supply of Samsung Bioepis’s ophthalmology biosimilars in the U.S. market. By leveraging Harrow’s strong local sales and distribution network, Samsung Bioepis aims to reduce the burden of direct commercialization while enhancing market penetration.
“We are pleased to partner with Harrow, a leading ophthalmic pharmaceutical company with proven commercial strength in the North American market,” said a Samsung Bioepis Business Development representative. “Through close collaboration with both Biogen and Harrow, we will ensure a seamless transition and continued service to customers and patients in the U.S.”
