Samsung Bioepis Co. Ltd. has entered into a license, development and commercialization agreement (DCA) with Harrow for Samsung Bioepis’ ophthalmology portfolio in the U.S. This includes:

• BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTISi (ranibizumab)
• OPUVIZ (aflibercept-yszy), a biosimilar referencing EYLEAii (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.

In October 2024, Biogen notified Samsung Bioepis of its decision to terminate the 2019 Development and Commercialization Agreement within the U.S. 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 the commercialization of BYOOVIZ and OPUVIZ in the U.S. upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis.

“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 U.S. market,” said Josh Sang Hyun Lee, Vice President and Business Development Team Leader at Samsung Bioepis. “Samsung Bioepis remains committed to expanding access and widening treatment options for healthcare systems, healthcare professionals, and patients, by providing affordable and high-quality biologic medicines around the world.”