In Harrow Inc.’s latest acquisition move, the company announced it is purchasing the exclusive U.S. commercial rights to Samsung Bioepis Co. Ltd.’s ophthalmic biosimilar portfolio—which includes two popular anti-vascular endothelial growth factor (VEGF) therapies indicated for retinal disease.
First, a rundown on Samsung Bioepis.
Headquartered in South Korea and a wholly-owned subsidiary of Samsung Biologics, the biopharmaceutical company is developing a pipeline of biosimilar candidates in ophthalmology as well as other therapeutic areas.
Notably: Its biosimilar pipeline and approved products have been distributed across global markets (including the United States) due in part to an extensive network of collaborators.
- Case in point: The company’s partnership with the Massachusetts-based Biogen, Inc. enabled the eventual FDA approval for OPUVIZ (aflibercept-yszy) in May 2024.
Tell me about the two biosimilars included in the Harrow deal.
The first is one we just referenced: OPUVIZ (pronounced op-u-vis).
Some background on it: This VEGF inhibitor (administered via intravitreal [IVT] injection) was FDA-approved in May 2024 as one of the first-ever interchangeables approved for Regeneron’s EYLEA (aflibercept 2 mg), indicated for the ophthalmic treatment of:
- Neovascular (wet) age-related macular degeneration (AMD)
- Macular edema following retinal vein occlusion (RVO)
- Branch or central RVO
- Diabetic macular edema (DME)
- Diabetic retinopathy (DR)
Take note, however: Unlike EYLEA, OPUVIZ is not approved for retinopathy of prematurity.
And its recommended dosing schedule?
See here for those details, separated by indication.
- And check out OPUVIZ’s full prescribing information (PI).
For warnings and precautions associated with the product’s use, see here and click here.
Now to this second biosimilar.
That would be BYOOVIZ (pronounced bio-viss; ranibizumab-nuna) injection 0.5 mg (10 mg/mL).
Its background: The IVT-injected biosimilar product was approved by the FDA in October 2023 as an interchangeable to Genentech’s Lucentis (ranibizumab) for the treatment of:
- Wet AMD
- Macular edema following RVO
- Myopic choroidal neovascularization (mCNV)
Talk about dosing and associated precautions.
The drug is formulated as a single-dose glass vial designed for IVT injection of 10 mg/mL in varying 0.5 mg dosing schedules—depending on the specific retinal disease indication.
- See here for those dosages.
And check out BYOOVIZ’s full PI for contraindications and warnings / precautions associated with use.
Now before we get to this deal—anything else to know about these drugs?
Yes, if only for the sake of big-picture context.
BYOOVIZ and OPUVIZ were both part of a 2019 exclusive commercialization agreement between Samsung and Biogen.
- During this time: Prior to its 2023 approval as a Lucentis interchangeable, BYOOVIZ was initially FDA approved in 2021 and later commercialized (by Biogen) in 2022—and, as we noted earlier, OPUVIZ also saw its approval in early 2024.
- However: In October 2024: Biogen notified Samsung of its intent to terminate the agreement in the United States and Canada.
- And as of 2025: The companies have worked together to transfer BYOOVIZ’s (and OPUVIZ, which was included in the agreement) North American commercialization rights back to Samsung—with the transition expected to be completed by the end of the year.
Duly noted. Next up: Harrow’s acquisition.
Harrow will take over full responsibility of BYOOVIZ’s and OPUVIZ’s U.S. commercialization only once Samsung’s aforementioned transition with Biogen is complete.
That’s it? No monetary mention?
None whatsoever. Glance reached out for further details on this as well (no details are being shared at the moment).
So what’s the intent behind this?
As the company noted, the purchase could potentially "substantially lower the financial burden on Medicare and commercial plans, while improving access and affordability for patients.”
- In support of this expanded access and affordability, Harrow has already partnered and kicked off several programs for patients to promote accessibility of its ophthalmic products across the United States.
And keep in mind: A generic product, by its very definition and purpose, is intended to work in the same way, provide the same clinical benefits, and be available at a lower price compared to its name-brand counterpart.
Okay, but what’s really in it for Harrow?
The answer: Opportunity for the company to enhance (and advance) its position as “the leading full-spectrum ophthalmic pharmaceuticals provider in the U.S.”
Give me a snapshot of U.S.’s current standing in this market.
North America is currently dominating the retinal biologics market, reportedly due in large part to an aging population and high prevalence for retinal diseases like AMD and DR across the United States.
- In the U.S. alone: The retinal biologics market reached a valuation of $9.7 billion in 2023.
And what’s the expectation on a global scale?
While the market was valued at $22.5 billion in 2023, projections clock its anticipated growth to be just under $50 billion by 2033—accompanied by an expected growth at a CAGR of 9.2% (from 2024 to 2032).