• Commercial launch opens up additional key markets in Europe and North America, making FYB201 available in a total of 17 countries worldwide
  • Lucentis® biosimilar FYB201 is an effective and cost-efficient treatment option for patients with serious retinal diseases
  • Commercialization partner Teva markets FYB201 in Canada under the trademark RanoptoTM and in Switzerland under the trademark Ranivisio®

Munich, Germany – Formycon AG (FSE: FYB) and Bioeq AG announce the commercial launch of FYB201, a biosimilar to Lucentis®1 (Ranibizumab), in Canada and Switzerland. The launch follows the marketing authorization granted by Health Canada under the trademark RanoptoTM2and Swissmedic under the trademark Ranivisio®3.

“Due to demographic developments, more and more people are affected by age-related macular degeneration and other retinal diseases, especially in industrialized nations. These diseases are often accompanied by a severe impairment in the quality of life. FYB201 is a new high-quality, effective and yet affordable treatment option for patients affected by such debilitating conditions. Teva is a strong commercialization partner with a proven track record in successfully launching FYB201 across major European markets and – like us – is convinced of the great potential of our biosimilar,” commented Nicola Mikulcik, CBO of Formycon AG.

FYB201 was developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV. As a biosimilar to Lucentis®, FYB201 has already proven to be an important, cost-effective treatment option for patients with severe retinal diseases in the USA and large parts of Europe. In mid-2021, Bioeq and Teva entered into a strategic partnership for the exclusive commercialization of FYB201 in Canada, Europe and other territories. In Canada and Switzerland, FYB201 has been approved for the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases.

The wet form of AMD is caused by excessive growth of blood vessels in the retina. The active ingredient ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of these blood vessels. In many developed countries, AMD is the leading cause of severe visual impairment or blindness. The risk of developing AMD increases with age. It is estimated that around 67 million people in Europe are currently affected[i], while around 2.5 million people in Canada suffer from AMD[ii]. The numbers are expected to continue to rise in the coming years.


1 Lucentis® is a registered trademark of Genentech Inc.
2 RanoptoTM is a trademark of Teva Canada Limited
3 Ranivisio® is a registered trademark of Bioeq AG

[i] Li JQ, Welchowski T, Schmid M, et al. Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis British Journal of Ophthalmology 2020;104:1077-1084.: https://bjo.bmj.com/content/104/8/1077.

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