FYB201/Ranivisio Launches in Europe as First Lucentis Biosimilar in Pre-Filled Syringe

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

FYB201/Ranivisio represents an advancement in ophthalmic care as the first ranibizumab biosimilar in Europe to be provided in a ready-to-use pre-filled syringe format. This new presentation is designed to streamline intravitreal treatment workflows, reduce preparation time, and minimize the risk of administration errors, ultimately supporting more efficient and consistent patient care.

The introduction of the pre-filled syringe format addresses long-standing clinical preferences by enhancing:

       • Dosing accuracy

       • Low injection pressure for patient comfort

       • Reduced risk of handling errors

Commercial Expansion Across Europe

Teva, the long-standing commercialization partner for FYB201's vial formulation since 2022, will now also market the pre-filled syringe version across Europe, improving regional accessibility and adoption in routine ophthalmic practice.

Approved Indications and Global Availability

FYB201/Ranivisio (ranibizumab) is indicated for the treatment of wet age-related macular degeneration (AMD) and other retinopathies leading to severe visual impairment, including diabetic macular edema and retinal vein occlusion.

The product is owned by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV. With this latest launch, FYB201 is now available in 21 countries across Europe, North America, and the MENA region.