Polpharma Biologics and partners have achieved a significant milestone in ophthalmic care with the commercial launch of Ranivisio® PFS (ranibizumab biosimilar pre-filled syringe) in France, marking the first Lucentis® biosimilar available in pre-filled syringe presentation across Europe.
The innovative pre-filled syringe configuration provides precise dosing and ease of use for treating patients with neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). Bioeq AG, a joint venture between Polpharma Biologics Group BV and Formycon AG, developed and licensed Ranivisio® PFS, while Teva Pharmaceutical Industries holds exclusive commercialization rights for France.
Advanced Pre-filled Syringe Technology
The pre-filled syringe technology has been specifically engineered for intravitreal injections, featuring high dosing accuracy, low injection pressure, and minimized risk of application errors. The silicon-oil free syringe device, combined with modern sterilization technology, establishes new standards in ophthalmic treatment delivery.
"The innovative PFS technology has been specifically designed for intravitreal injections and is characterized by high dosing accuracy, low injection pressure, and a minimized risk of application errors – key factors in ophthalmic care," according to the development partners.
The ready-to-use syringe reduces preparation time and supports efficient administration, streamlining clinical workflows while offering features highly valued by ophthalmologists in daily practice.
Manufacturing and Supply Chain
The drug substance for Ranivisio® PFS is manufactured by Polpharma Biologics S.A., operating under the Rezon Bio brand at facilities in Poland. Rezon Bio ensures commercial supply of the drug substance, maintaining consistent quality and reliability throughout the manufacturing process.
Market Expansion Strategy
Following the French launch in October 2025, additional European countries including Germany will receive the product through a staggered rollout approach. This expansion strategy leverages Teva's extensive distribution network and commercial experience in biosimilars across Europe.
"The launch of our FYB201 pre-filled syringe is another testament to Formycon's outstanding development expertise paired with innovation power," said Dr. Stefan Glombitza, CEO of Formycon. "By introducing the first ranibizumab biosimilar in this modern pre-filled syringe presentation, we are setting new standards in convenience, safety and efficiency for ophthalmic treatments."
Michał Nitka, Teva SVP Head Generics Europe & Global Head OTC, emphasized the partnership's alignment with Teva's strategic objectives: "Through our partnership with Formycon, we are accelerating the availability of therapies and broadening Teva's biosimilars portfolio, in line with our Pivot to Growth strategy."
Clinical Applications and Market Impact
FYB201/Ranivisio® treats severe visual impairments including wet age-related macular degeneration and other retinopathies. The biosimilar product is currently available in 21 countries across Europe, North America, and the MENA region, with Teva serving as the established commercialization partner for the vial presentation since 2022.
The introduction of the pre-filled syringe format significantly expands market reach and therapeutic access, combining Teva's commercial expertise with Formycon's biosimilar development capabilities for highly regulated markets.
"The launch of Ranivisio® PFS in France is another important step in our mission to broaden access to biologic medicines," stated Anjan Selz, CEO of Polpharma Biologics. "With the first Lucentis® biosimilar available in a pre-filled syringe in Europe, we are setting a new standard for ophthalmic treatment."
