Samsung Bioepis Launches OPUVIZ Aflibercept Biosimilar Across Europe

01 June 2026 | Monday | News


European rollout of OPUVIZ strengthens Samsung Bioepis’ ophthalmology portfolio, expands access to biosimilar eye care treatments, and marks the company's fifth directly commercialised biosimilar in the region.

  • OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea (aflibercept), will be rolled out across Europe, starting today
  • Launch 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 2026
  • Marks fifth biosimilar product to be directly commercialized by Samsung Bioepis in Europe
  • OPUVIZ 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 announced the launch of OPUVIZ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea1 (aflibercept), across Europe, starting today.

We are pleased to launch OPUVIZ in Europe, marking a significant milestone in expanding patient access to ophthalmology treatments.

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™.

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