Samsung Bioepis Launches OPUVIZ™ (Aflibercept) 40 mg/mL Vial Across Europe, to Treat Ophthalmic Conditions

OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea (aflibercept), will be rolled out across Europe, starting todayLaunch strengthens Samsung Bioepis ophthalmology portfolio in Europe, after the company began direct commercialization of BYOOVIZ™(ranibizumab) 10 mg/mL solution for injection in a vial in January 2026Marks fifth biosimilar product to be directly commercialized by Samsung Bioepis in EuropeOPUVIZ 40 mg/mL solution for injection in pre-filled syringe has obtained positive opinion from the Committee for Medicinal Products for Human use (CHMP) in November 2025, and is expected to be available in the market in the third quarter of this year

Samsung Bioepis Co., Ltd. today announced the launch of OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea¹ (aflibercept), across Europe, starting today.

OPUVIZ marks the fifth biosimilar product to be directly commercialized by Samsung Bioepis. It builds on other key biosimilar milestones in Europe this year, including the initiation of direct commercialization of BYOOVIZ™ (ranibizumab) 10 mg/mL solution for injection in a vial, as well as the launch of XBRYK™ (denosumab) 120 mg solution for injection in a vial in January.

“We are pleased to launch OPUVIZ in Europe, marking a significant milestone in expanding patient access to ophthalmology treatments,” said Antonio Rito, Vice President and Head of Europe, at Samsung Bioepis. “Leveraging our direct commercialization capabilities, we will work closely with healthcare professionals and payers to facilitate access to this important medicine, so that patients can benefit from quality-assured, safe and effective biosimilar alternatives.”

In January 2026, Samsung Bioepis announced that the company signed a settlement and license agreement with Regeneron and Bayer concerning the commercialization of its biosimilar to Eylea 2 mg (aflibercept 40 mg/mL solution) in Europe and the Rest of the World (RoW).²

Samsung Bioepis’s aflibercept biosimilar is also available in the Republic of Korea under the brand name AFILIVU™.

About OPUVIZ

OPUVIZ contains the active ingredient (aflibercept), a vascular endothelial growth factor (VEGF) inhibitor, acting as a recombinant fusion protein designed to block abnormal blood vessel growth and leakage in the eye.

OPUVIZ was first approved as 40 mg/mL solution for injection in a vial by the European Commission (EC) in November 2024 and by the Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025 for adults for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV).^3,4

OPUVIZ 40 mg/mL solution for injection in pre-filled syringe has later obtained positive opinion from the CHMP in November 2025 for the same indications as the vial presentation.

OPUVIZ SELECT IMPORTANT SAFETY INFORMATION

The safety of OPUVIZ has been evaluated and, on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine, Eylea.

For the complete list of side effects and restrictions of OPUVIZ, see the package leaflet.

The most common side effects with OPUVIZ are conjunctival haemorrhage, retinal haemorrhage, reduced vision and eye pain. Other common side effects are vitreous detachment, cataract, vitreous floaters and increased intraocular pressure.

Serious injection-related side effects are blindness, endophthalmitis, cataracts, increased intraocular pressure, vitreous haemorrhage and vitreous or retinal detachment.

OPUVIZ must not be used in patients who have or are thought to have ocular or periocular infections, or in patients who have severe inflammation inside the eye.

BYOOVIZ SELECT IMPORTANT SAFETY INFORMATION

The safety of BYOOVIZ has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Lucentis.

The most common side effects with ranibizumab are increased intraocular pressure, headache, vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, eye pain, vitreous floaters, conjunctival haemorrhage, eye irritation, sensation of a foreign body in the eye, increased lacrimation, blepharitis, dry eye, ocular hyperaemia, eye pruritis, arthralgia and nasopharyngitis. Rarely, endophthalmitis, blindness, serious damage to the retina and cataract can occur.

BYOOVIZ must not be used in patients who may have an infection of the eye or of the area around the eye, or who have severe inflammation within the eye. For the full list of side effects and restrictions of BYOOVIZ, see the package leaflet.

XBRYK SELECT IMPORTANT SAFETY INFORMATION

The safety of denosumab in XBRYK has been evaluated and on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine, Xgeva.

For the complete list of side effects and restrictions with XBRYK, see the package leaflet.

The most common side effects with XBRYK include hypocalcaemia, pain in the muscles and bones, dyspnoea and diarrhoea. Other common side effects are development of another form of cancer in patients with advanced cancer, hypophosphataemia, excessive sweating, tooth loss and osteonecrosis in the jaw.

Hypocalcaemia mostly occurs within the first 2 weeks of starting treatment and can be severe; however, it can be managed with calcium and vitamin D supplementation.

XBRYK must not be used in patients with wounds from dental or mouth surgery that have not yet healed, or in people with severe, untreated hypocalcaemia.

DISCLAIMER

This press release is intended solely for the purpose of sharing the availability of OPUVIZ in Europe. 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. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

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