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

The launch follows the European introduction of OPUVIZ in vial presentation earlier this year and provides ophthalmologists with an additional administration option for the treatment of retinal diseases.

“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,” said Antonio Rito, Vice President and Head of Europe, Samsung Bioepis. “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.”

Samsung Bioepis launched OPUVIZ 40 mg/mL solution for injection in a vial in Europe in May 2026. The company’s aflibercept biosimilar is also available in South Korea under the brand name AFILIVU.

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

The European Commission first approved OPUVIZ 40 mg/mL solution for injection in a vial in November 2024, followed by approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025. 

The biosimilar is indicated for adults with neovascular or wet age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO), diabetic macular oedema (DME), and myopic choroidal neovascularisation (myopic CNV).

The OPUVIZ pre-filled syringe presentation subsequently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in November 2025 for the same indications as the vial presentation.