Samsung Bioepis Launches OPUVIZ (Aflibercept) 40 mg/mL Pre-Filled Syringe Across Europe

• OPUVIZ 40 mg/mL solution in pre-filled syringe (PFS) becomes available in Europe starting today, following the launch of vial presentation in May 2026
• PFS presentation offers convenience for healthcare professionals through ready-to-use, single-dose delivery system

Samsung Bioepis Co., Ltd. today announced the launch of OPUVIZ 40 mg/mL solution in pre-filled syringe (PFS), a biosimilar referencing Eylea¹ (aflibercept), across Europe, starting today.

“We are pleased to introduce the pre-filled syringe presentation of OPUVIZ to the European market, building on the momentum of our recent European launch of OPUVIZ vial earlier this year. With enhanced convenience for injection and improved dosing accuracy compared to the vial, OPUVIZ PFS will offer an additional option for ophthalmologists to help manage retinal diseases effectively,” said Antonio Rito, Vice President and Head of Europe, at Samsung Bioepis. “We will continue to bring meaningful value to healthcare professionals and patients in Europe by offering quality-assured, safe and effective biologic options.”

Samsung Bioepis launched OPUVIZ 40 mg/mL solution for injection in a vial in May this year. Samsung Bioepis’ 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).^2,3

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.

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, visit www.samsungbioepis.com.

¹ Eylea is a trademark of Bayer AG.

² OPUVIZ EMA Summary of Product Characteristics (SmPC). Available at: https://www.ema.europa.eu/en/documents/product-information/opuviz-epar-product-information_en.pdf (Accessed August 2026)

³ OPUVIZ MHRA Summary of Product Characteristics (SmPC). Available at: https://mhraproducts4853.blob.core.windows.net/docs/b6b7a3d69da03de64842a8ed268aa84bcf6841ea (Accessed August 2026)