South Korean firm Samsung Bioepis has signed a license, development, and commercialisation agreement with Harrow, a leading North American eyecare pharmaceutical company, for its ophthalmology biosimilar portfolio in the United States.  

The agreement covers BYOOVIZ (ranibizumab-nuna), a biosimilar of LUCENTIS (ranibizumab), and OPUVIZ (aflibercept-yszy), a biosimilar of EYLEA (aflibercept).   The deal 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 in the US and Canada. Since then, both companies have been working closely to ensure a smooth transfer of rights.

Following the transition, Harrow will assume full responsibility for the commercialisation of both BYOOVIZ and OPUVIZ in the US.  

 “We are pleased to partner with Harrow, a leading eyecare pharmaceutical company with strong capabilities in commercialization of ophthalmic pharmaceutical products in the North American market,” said Josh Sang Hyun Lee, Vice President and Business Development Team Leader at 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 US market,” Lee added.

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). It has been commercially available in the US since June 2022.

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).  

Samsung Bioepis has also received a certification on ISO 37301 (Compliance Management Systems) from the British Standards Institution (BSI), reinforcing its commitment to ensuring adherence to laws, regulations and ethical standards.

“This ISO certification is a testament that Samsung Bioepis upholds highest standards for compliance to regulations and organisational governance,” said Kyung-Ah Kim, President and Chief Executive Officer at Samsung Bioepis.

“We will keep implementing rigorous standards and practices in our compliance management system to continue to build trust and enhance our reputation among our stakeholders,” he added.

ISO 37301 provides global guidelines for establishing, maintaining, and improving an effective compliance management system. This new certification adds to Samsung Bioepis’s growing list of international recognitions, including ISO 27001 (Information Security Management), ISO 45001 (Occupational Health & Safety) received in August 2023, and ISO 14001 (Environmental Management) and ISO 50001 (Energy Management) achieved in September 2022.

ISO 37301 is an international standard for compliance management systems (CMS). It provides guidelines for establishing, developing, implementing, evaluating, maintaining, and improving an effective and responsive compliance management system within organisations.

This new certification adds to Samsung Bioepis’s growing list of international recognitions, including ISO 27001 (Information Security Management), ISO 45001 (Occupational Health and Safety) received in August 2023, and ISO 14001 (Environmental Management) and ISO 50001 (Energy Management) achieved in September 2022.