Harrow Inc. has re-launched BYOOVIZ (ranibizumab-nuna) to the U.S. commercial market as part of a commercialization rights partnership with Samsung Bioepis Co., Ltd.
First up: Tell me about BYOOVIZ.
Pronounced bio-viss, BYOOVIZ is an intravitreally (IVT)-administered injection intended for the treatment of:
- Wet age-related macular degeneration (AMD)
- Macular edema following retinal vein occlusion (RVO)
- Myopic choroidal neovascularization (mCNV)
Importantly: It was initially approved by the FDA in 2021 as the first ophthalmic biosimilar in the U.S before receiving interchangeable designation in October 2023 as a biosimilar to Genentech’s Lucentis (ranibizumab).
To note, however: It is not approved for two of Lucentis’s retinal indications: diabetic macular edema (DME) and diabetic retinopathy (DR).
Hold up—remind me what interchangeable designation means.
Basically, this applies to an FDA-approved biosimilar that meets additional requirements proving that alternating (or switching) between it and its original reference product carries no greater risk of adverse effects than sticking with the original.
Take note: While standard biosimilars require a new prescription, an interchangeable biosimilar can be automatically substituted for the reference product by a pharmacist—without consulting the prescribing physician.
- This is similar to how generic drugs can be swapped for name-brand drugs.
Ah, gotcha. So what does BYOOVIZ’s dosing look like?
The biosimilar is packaged 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 give me some background on its development and commercialization.
Its development can be traced back to Samsung Bioepis (which is actually a joint venture between Samsung BioLogics and Biogen Inc.).
However, its commercialization (marketing rights) have shifted:
- As part of a 2019 deal with Samsung, Biogen acquired the exclusive U.S. and Canadian commercialization rights.
- BYOOVIZ made its initial U.S. debut in 2022.
- It was then granted interchangeable designation by the FDA in 2023 as a biosimilar to Lucentis.
- Fast forward to 2024, that deal was terminated and the rights were transferred back to Samsung.
- But then, in July 2025, Harrow announced it would purchase those rights (along with OPUVIZ [aflibercpt-yszy], another FDA-approved biosimilar).
That’s quite the journey. So where can BYOOVIZ be purchased?
Good question. Considering it’s not yet listed on Harrow’s product page, we’d recommend reaching out to the company directly for more information on availability.