The CHMP issued a positive opinion for the pre-filled syringe. Credit: Me dia / Shutterstock.com.

Samsung Bioepis has started direct commercialisation of Byooviz, a biosimilar to Genentech’s Lucentis (ranibizumab), in Europe.

The company has assumed commercial rights for Byooviz from Biogen, and the product will now be available as a Samsung Bioepis brand across several European countries as part of its ongoing expansion.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

In August 2021, Byooviz received approval from the European Commission (EC) as a single-use vial for intravitreal administration (0.5mg/0.05ml).

It is indicated for the treatment of visual impairment due to diabetic macular oedema, neovascular (wet) age-related macular degeneration, proliferative diabetic retinopathy, visual impairment due to choroidal neovascularisation, and visual impairment due to macular oedema secondary to retinal vein occlusion (branch or central).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the Byooviz pre-filled syringe (PFS) in November 2025. The syringe is anticipated to enter the European market in the second quarter of 2026.

Samsung Bioepis vice-president Antonio Rito said: “This is a significant milestone for Samsung Bioepis as the company continues to strengthen its presence in Europe by expanding its portfolio of directly commercialised products.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

“Leveraging the past three years of experience with Epysqli (eculizumab) and the newly launched Obodence (denosumab) and Xbryk (denosumab) in Europe, we will continue on our journey to become a fully integrated biopharmaceutical company with end-to-end capabilities from development to commercialisation.

“We will work closely with payers and healthcare professionals to ensure seamless access to our biosimilar medicines for patients in need.”

In September 2023, Sandoz partnered with Samsung Bioepis to develop and market a Stelara (ustekinumab) biosimilar in the US, Canada, and Europe.

Pharmaceutical Technology Excellence Awards - Nominations Closed

Nominations are now closed for the Pharmaceutical Technology Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact.

Excellence in Action
Awarded the 2025 Pharmaceutical Technology Excellence Award for Business Expansion in Integrated Manufacturing, Upperton Pharma Solutions is rapidly expanding its UK GMP and sterile manufacturing footprint. Find out how Upperton’s integrated CDMO model helps pharma companies move from early development to clinical and niche commercial supply with fewer handovers and faster timelines.

Discover the Impact