First Lucentis Biosimilar Available in Pre-Filled Syringe Launched in Europe

Formycon, Bioeq AG, and Teva Pharmaceutical announced the European launch of FYB201/Ranivisio, the first Lucentis biosimilar available in an EMA-approved pre-filled syringe (PFS) presentation. The rollout began in France in October 2025, with additional markets, including Germany, to follow in a staggered launch across Europe.

FYB201/Ranivisio marks a milestone as the first Lucentis biosimilar in Europe to be offered as a ready-to-use pre-filled syringe, simplifying treatment for patients and clinicians. The new presentation aims to enhance efficiency and convenience in ophthalmic care, reducing preparation time and minimizing the risk of application errors.

Teva, Bioeq’s commercialization partner for the vial formulation since 2022, will now also market the PFS version, expanding accessibility across the region. 

The innovative PFS technology, developed specifically for intravitreal injections, is designed to deliver:

• High dosing accuracy

• Low injection pressure

• Reduced risk of application errors

FYB201/Ranivisio (ranibizumab) is indicated for the treatment of wet AMD and other retinopathies causing severe visual impairment. Owned by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV, FYB201 is now available in 21 countries across Europe, North America, and the MENA region.