Munich, Amsterdam, Zug, Toronto – Formycon AG, Polpharma Biologics Group BV, Bioeq AG and Teva Canada Ltd. jointly announce that Health Canada has granted the “Notice of Compliance” (NOC) for Ranopto®1 (Ranibizumab), a biosimilar to Lucentis®2, for the treatment of several serious retinal diseases in Canada.

Ranopto® is indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD), the treatment of visual impairment due to diabetic macular oedema (DME) or choroidal neovascularization (CNV), as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (RVO).

FYB201/Ranopto® was developed by Bioeq, a Joint Venture between Formycon and Polpharma Biologics. Mid 2021, Teva Pharmaceutical Industries Ltd. (“Teva”) entered into a strategic partnership for the exclusive commercialization of FYB201 in Canada, Europe and selected other countries. Commercial launch by Teva Canada Ltd. is expected to start in the first quarter of 2024.

AMD is caused by excessive growth of blood vessels in the retina. Ranibizumab inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of these blood vessels in the retina. In developed countries AMD is the most common cause of severe visual impairment or blindness. The risk of being affected increases with age. In Canada, approximately 2.5 million people are affected by AMD with nearly 180,000 experiencing vision loss[i].

“After successful launches in the U.S., Europe and countries of the MENA region, we are very pleased that – together with our partner Teva – we are now able to provide a highly effective and affordable treatment option to patients in Canada with severe retinal diseases. With the second highest per capita sales and third highest per capita consumption in the OECD, anti-VEGF therapies in Canada have been a significant burden on public drug plans in the past. With our biosimilar, we can contribute to more competition and cost efficiency in this important therapeutic area”, says Dr. Stefan Glombitza, CEO of Formycon AG.

“The approval in Canada underlines the excellent work we have done together with our partners in the development of FYB201/Ranopto®. It brings us a big step closer to our goal of improving therapy access for people with nAMD and other prevalent eye diseases worldwide, and thereby contributing to a better quality of life for millions of people affected”, says Konstantin Matentzoglu, Supervisory Board Member of Polpharma Biologics Group.

“Teva Canada is very pleased along with our partners to launch Ranopto®. This marks an important milestone for our growing biosimilar portfolio and a new treatment option for Canadian patients with severe retinal disease as well as healthcare professionals”, says Michael Sine, General Manager Teva Canada.


1Ranopto® is a registered trademark of Bioeq AG.
2Lucentis® is a registered trademark of Genentech, Inc.

[i] Larissa Moniz, Chad Andrews, Jennifer Pereira: „Canadian patient experience with age-related macular degeneration“ in ARVO Annual Meeting Abstract, June 2022