Samsung Bioepis Co., Ltd. today announced the relaunch of BYOOVIZ® (ranibizumab-nuna) in the United States (US), in partnership with Harrow (Nasdaq: HROW). Harrow became responsible for commercialization of BYOOVIZ® (ranibizumab-nuna), a biosimilar referencing LUCENTIS1 (ranibizumab), and OPUVIZ™ (aflibercept-yszy), a biosimilar referencing EYLEA2 (aflibercept), upon full transition of commercialization rights from Biogen back to Samsung Bioepis by the end of 2025.
BYOOVIZ was approved by the U.S. 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).3 BYOOVIZ was granted interchangeability designation by the FDA in October 2023.4
Wet AMD affects approximately 1.2% to 1.3% of adults aged 65 and older in the US, with 1.5 million Americans living with the late, vision-threatening stages of the disease.5,6 Over the past two decades, anti-VEGF therapy has become a standard treatment for wet AMD.7 However, cost remains a significant financial burden for ranibizumab and other anti-VEGF treatments in the US.8 Biosimilars are biological products that are highly similar to existing FDA-approved reference products with no clinically meaningful differences in safety, purity, or potency and have the potential to alleviate the financial burden associated with current anti-VEGF therapies.9
“Today marks an exciting new chapter for BYOOVIZ in the US. As the first FDA-approved biosimilar to Lucentis, BYOOVIZ has already demonstrated its value in expanding access to critical retinal disease treatments. With Harrow now leading commercialization efforts, we are reigniting our commitment to ensuring patients and retina specialists across America to have access to this quality-proven, safe and effective biosimilar option,” said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial, Samsung Bioepis. “We believe this relaunch will ultimately help more patients with critical ophthalmic diseases to receive the vision-saving treatments they need.”
In July 2025, Samsung Bioepis entered into partnership with Harrow for commercialization of BYOOVIZ and OPUVIZ in the US. Samsung Bioepis is responsible for development, regulatory registration, and manufacture of the products, while Harrow is responsible for commercialization.
BYOOVIZ was also approved as the first ophthalmology biosimilar by the European Commission and the United Kingdom in August 2021, and in Canada in March 2022. In Europe, Samsung Bioepis is responsible for direct commercialization of BYOOVIZ.
About BYOOVIZ (ranibizumab-nuna)
BYOOVIZ (ranibizumab-nuna) injection, for intravitreal use.
BYOOVIZ (ranibizumab-nuna) is an interchangeable biosimilar to LUCENTIS (ranibizumab injection).
BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:
Neovascular (Wet) Age-Related Macular Degeneration (AMD)
Macular Edema Following Retinal Vein Occlusion (RVO)
Myopic Choroidal Neovascularization (mCNV)
Select Important Safety Information
WARNING AND PRECAUTIONS
Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection.
Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection.
There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
ADVERSE REACTIONS
The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP.
Please see Prescribing Information for BYOOVIZ (ranibizumab-nuna) HERE.
About OPUVIZ (aflibercept-yszy)
OPUVIZ (aflibercept-yszy) injection, for intravitreal use.
OPUVIZ (aflibercept-yszy) is an interchangeable biosimilar to EYLEA (aflibercept).
OPUVIZ is a vascular endothelial growth factor (VEGF) inhibitor, indicated for the treatment of patients with:
Neovascular (Wet) Age-Related Macular Degeneration (AMD)
Macular Edema Following Retinal Vein Occlusion (RVO)
Diabetic Macular Edema (DME)
Diabetic Retinopathy (DR)
Select Important Safety Information
WARNING AND PRECAUTIONS
Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.
Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.
There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
ADVERSE REACTIONS
The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.
Please see Prescribing Information for OPUVIZ (aflibercept-yszy) HERE.
DISCLAIMER
This press release is intended solely for the purpose of sharing the availability of BYOOVIZ in the US. This document should not be construed as medical advice or as an endorsement of any product or treatment. Regulatory approval status and prescribing information may vary by country; please refer to local product information for any medicinal products mentioned herein. Information in this press release may include data on investigational compounds or unapproved indications. Such information is shared for scientific discussion purposes only and does not represent an assertion of safety or efficacy for any unapproved use.
This press release may contain forward-looking statements, including statements regarding clinical development programs, regulatory submissions, potential approvals, and future therapeutic potential. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. Forward-looking statements are not guarantees of future performance. Samsung Bioepis undertakes no obligation to update any forward-looking statements contained in this press release.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology and neurology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.
About Harrow
Harrow, Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and diseases of the retina. Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn.
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1 Lucentis is a trademark of Genentech, Inc. |
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2 Eylea is a trademark of Regeneron Pharmaceuticals, Inc. |
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3 U.S. Food and Drug Administration. FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions. Press Release. Sep 20, 2021. Available at: https://www.prnewswire.com/news-releases/fda-approves-first-biosimilar-to-treat-macular-degeneration-disease-and-other-eye-conditions-301380552.html (Accessed June 2026) |
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4 U.S. Food and Drug Administration. Supplement Approval for Byooviz (ranibizumab-nuna) injection 0.5 mg (10 mg/mL) for intravitreal injection (BLA 761202/S-006). Available at: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761202Orig1s006ltr.pdf (Accessed June 2026) |
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5 Saundankar V, Borns M, Broderick K, Shah B, Cowburn S, McFadden S, Suehs B. Annual prevalence of geographic atrophy and wet age-related macular degeneration among Medicare Advantage enrollees in a US health plan. J Manag Care Spec Pharm. 2025 Jan;31(1):88-94. doi: 10.18553/jmcp.2025.31.1.88. PMID: 39745845; PMCID: PMC11695844. |
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6 Center for Disease Control and Prevention. Vision and Eye Health Surveillance System. VEHSS Modeled Estimates: Age-Related Macular Degeneration (AMD). Available at: https://www.cdc.gov/vision-health-data/prevalence-estimates/amd-prevalence.html (Accessed June 2026) |
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7 Kovach JL, Schwartz SG, Flynn HW Jr, Scott IU. Anti-VEGF Treatment Strategies for Wet AMD. J Ophthalmol. 2012;2012:786870. doi: 10.1155/2012/786870. Epub 2012 Feb 28. PMID: 22523653; PMCID: PMC3317200. |
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8 Tabano D, Watane A, Gale R, Cox O, Hill SR, Longworth L, Oluboyede Y, Ahmed A, Patel NA. The Economic Burden of Anti-Vascular Endothelial Growth Factor on Patients and Caregivers in the UK, Europe, and North America. Ophthalmol Ther. 2025 Aug;14(8):1869-1892. doi: 10.1007/s40123-025-01180-5. Epub 2025 Jun 28. PMID: 40580375; PMCID: PMC12270987. |
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9 U.S. Food and Drug Administration. Biosimilars: Overview for Health Care Professionals. Available at: https://www.fda.gov/drugs/biosimilars/overview-health-care-professionals (Accessed June 2026) |
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