Harrow Secures Exclusive U.S. Rights for Samsung Bioepis' Ophthalmology Biosimilars

Harrow has entered into a commercialization agreement with Samsung Bioepis for exclusive US rights to its ophthalmology biosimilars portfolio, including BYOOVIZ and OPUVIZ. The acquisition strengthens Harrow's market position in the $9 billion US retinal disease treatment sector and is expected to complete by end of 2025. BYOOVIZ and OPUVIZ are used to treat sight-threatening retinal diseases such as Wet Age-Related Macular Degeneration. Harrow's CEO sees this move as a potential game-changer in the Wet AMD treatment landscape by providing affordable alternatives to existing therapies.

Harrow Inc. has entered into a commercialization agreement with Samsung Bioepis for exclusive US rights to its ophthalmology biosimilars portfolio, including BYOOVIZ and OPUVIZ. The acquisition strengthens Harrow's market position in the $9 billion US retinal disease treatment sector and is expected to complete by the end of 2025.

BYOOVIZ and OPUVIZ are used to treat sight-threatening retinal diseases such as Wet Age-Related Macular Degeneration (AMD). Harrow's CEO, Mark L. Baum, sees this move as a potential game-changer in the Wet AMD treatment landscape by providing affordable alternatives to existing therapies.

The transition of commercial rights from Biogen to Samsung Bioepis is expected to complete by the end of 2025. Previously, BYOOVIZ was commercialized by Biogen in the US since its initial launch in June 2022. However, Biogen notified Samsung Bioepis of its decision to terminate the 2019 Development and Commercialization Agreement within the US and Canada in October 2024.

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). 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).

The agreement will allow Harrow to leverage its established commercial infrastructure to market these biosimilars, which are designed to provide more affordable alternatives to existing anti-VEGF therapies for retinal diseases. The strategic acquisition comes as Biogen, the previous U.S. distributor for BYOOVIZ since its launch in June 2022, decided to terminate their agreement with Samsung Bioepis by October 2024. Harrow will assume full commercialization responsibilities for these biosimilars once the transition of rights is finalized, anticipated by the end of 2025.

Harrow's acquisition of these products has the potential to "substantially lower the financial burden on Medicare and commercial plans, while improving access and affordability for patients." The company states this is due to current anti-VEGF therapies being among the most expensive drug categories covered under Medicare Part B, with annual spending in the US exceeding $4.2 billion [1].

References:
[1] https://www.ophthalmologytimes.com/view/harrow-enters-into-agreement-with-samsung-bioe-for-commercial-rights-to-its-ophthalmology-biosimilar-portfolio
[2] https://www.gurufocus.com/news/2983601/harrow-enters-into-commercialization-agreement-with-samsung-bioepis-for-ophthalmology-biosimilars-portfolio-in-the-united-states-hrow-stock-news
[3] https://www.investing.com/news/company-news/harrow-acquires-exclusive-us-rights-to-samsung-bioepis-eye-drugs-93CH-4139400