Formycon is a biotechnology company developing biosimilars. The main lead is FYB201, a Lucentis biosimilar candidate that has completed Phase III and is entering regulatory review. FYB203 is an Eylea candidate biosimilar in preclinical. They are both out-licensed. FYB202, a biosimilar candidate of Stelara, is being developed in a joint venture.
Formycon progressed all key projects in H121. FYB201 (partnered with Bioeq) is a Lucentis biosimilar to treat neovascular age-related macular degeneration (nAMD). The US FDA is reviewing the BLA with an August 2022 decision due; the European EMA review should complete in mid-2021. FYB201 will be marketed by Teva in Europe and by Coherus in the US. FYB202 (a Stelara biosimilar in a joint venture with Aristo Pharma) is waiting for its Phase III readout in psoriasis. FYB203 (an Eylea biosimilar partnered with Klinge) is in late Phase III in nAMD. FYB207 is a novel COVID-19 therapy with a €12.7m grant and H122 Phase I/IIa trials planned. Formycon had €33.6m cash on 30 June 2021. H121 revenue was €20.3m (H120: €16.5m). The loss rose to €10.2m (FY20: loss of €5.9m) due to investment into unpartnered projects.