Harrow, Inc. announced a definitive agreement with Samsung Bioepis Co. Ltd. to secure the exclusive U.S. commercial rights to its ophthalmology biosimilar portfolio. This portfolio includes BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTIS, and OPUVIZ (aflibercept-yszy), a biosimilar referencing EYLEA. These are two of the most widely used anti-VEGF therapies for retinal diseases.
Harrow will assume full commercial responsibility for BYOOVIZ and OPUVIZ in the U.S. upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis, which is expected by the end of 2025. This strategic acquisition enhances Harrow's position as a full-spectrum ophthalmic pharmaceuticals provider and expands its pipeline into high-value biosimilars for sight-threatening retinal diseases.
The U.S. market for current anti-VEGF therapies exceeds $4.2 billion annually, making this a significant opportunity for Harrow. The company aims to reshape the Wet AMD treatment landscape by offering FDA-approved, on-label, and affordable alternatives. BYOOVIZ was FDA-approved in September 2021, and OPUVIZ was approved in May 2024, both with interchangeability status.
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