Samsung Bioepis has handed over commercial responsibility for its two eye disease biosimilars to Harrow, a Nashville-based pharmaceutical company, following Biogen’s decision to abandon the partnership.
The South Korean biotechnology firm announced it entered a licensing agreement with Harrow for BYOOVIZ and OPUVIZ, biosimilars that reference blockbuster treatments Lucentis and Eylea respectively. The transition becomes effective once Samsung Bioepis reclaims commercial rights from Biogen by year-end.
Biogen notified Samsung Bioepis in October 2024 of its intention to terminate their 2019 development and commercialization partnership for the US and Canadian markets. The termination leaves Samsung Bioepis scrambling to find new distribution partners for products in a competitive market where biosimilars have struggled to gain meaningful traction.
The eye treatment market presents unique challenges for biosimilar adoption. Eylea commands a 43.4% market share, while off-label use of cheaper Avastin accounts for 34% of treatments, leaving limited room for biosimilar alternatives to expensive branded drugs.
Harrow characterized the deal as providing access to a $9 billion retinal disease treatment market, though financial terms were not disclosed. The company claims the biosimilars could reduce Medicare spending on anti-VEGF therapies, which currently exceeds $4.2 billion annually.
BYOOVIZ became the first FDA-approved ophthalmology biosimilar in September 2021 and has been commercially available since June 2022. OPUVIZ received approval in May 2024. However, uptake of ranibizumab biosimilars has disappointed, as physicians increasingly favor newer treatments over the Lucentis reference product.
The partnership reflects the challenging dynamics facing biosimilar manufacturers in ophthalmology, where established treatment patterns and physician preferences have proven resistant to cost-based competition.
