Harrow Launches BYOOVIZ Interchangeable Ranibizumab Biosimilar Across U.S. Retina Market

Supply reliability in the anti-VEGF segment just became a sharper operational concern: Harrow has commercially launched BYOOVIZ® (ranibizumab-nuna), an FDA-designated interchangeable biosimilar referencing LUCENTIS, under an exclusive U.S. commercialization agreement with Samsung Bioepis. The interchangeability designation, the first granted to an ophthalmology biosimilar in the U.S., allows substitution at the pharmacy level without prescriber intervention, a distinction that carries direct implications for formulary positioning and buy-and-bill procurement decisions at retina practices.

BYOOVIZ carries FDA approval across three indications: Neovascular (Wet) Age-Related Macular Degeneration, Macular Edema following Retinal Vein Occlusion, and Myopic Choroidal Neovascularization. The Samsung Bioepis agreement also grants Harrow exclusive U.S. rights to OPUVIZ® (aflibercept-yszy), an FDA-approved biosimilar referencing EYLEA, extending the company's biosimilar footprint across two of the dominant anti-VEGF reference products in a market estimated at $9 billion annually.

For QA directors and regulatory leads at biosimilar manufacturers, the BYOOVIZ launch illustrates how interchangeability designation translates into a measurable commercial advantage, one that requires demonstrating switching study data meeting FDA's interchangeability standard under the Biologics Price Competition and Innovation Act. Manufacturers pursuing similar designations in ophthalmology or adjacent biologics categories should read this launch against the agency's existing guidance on switching study design, where three alternating exposures between reference and biosimilar remain the accepted evidentiary threshold.

From a supply-chain standpoint, the clinical rationale is direct: a vitreoretinal surgeon at Tyler Retina Consultants cited inconsistent product availability as a driver for adopting BYOOVIZ, noting that ranibizumab-referenced biosimilars have cycled in and out of supply. Harrow's buy-and-bill model, already established through IHEEZO® and TRIESENCE® within retina practices, positions the company to absorb BYOOVIZ into existing distribution channels without requiring new contracting infrastructure at the practice level.

The measurable outcome to monitor is market uptake velocity against the interchangeable designation, specifically, whether payer formulary decisions and group purchasing organization contracts align with the interchangeability status in the near-term contracting cycle.

Source: Harrow, Inc. via GlobeNewswire, July 1, 2026.