Formycon has announced its half-year financial results, reporting Group revenue of €26.9 million and a 2024 revenue forecast remaining between €55-€65 million, driven by its biosimilar pipeline and projects.
This includes the “strong performance” of FYB201, biosimilar to Lucentis® (ranibizumab), which is reported to have achieved over 45% market share in the US and a 79% share of the UK market based on indication-specific market volume. FYB201 was developed by Bioeq (a JV between Formycon and Polpharma Biologics). It has been approved in the UK (in May 2022, marketed as Ongavia® by Teva), in the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024) the EU (in August 2022, marketed as Ranivisio® by Teva), Canada (in December 2023, marketed as RanoptoTM by Teva) and MENA (marketed as Ravegza® by MS Pharma).
Formycon also highlights the June 2024 US approval of its FYB203 (Ahzantive®), biosimilar to Regeneron’s Eylea® (aflibercept). Formycon expects European approval “by early 2025 at the latest”.
In July 2024, Formycon and its commercialisation partner, Fresenius Kabi, received a positive CHMP opinion for FYB202, biosimilar to J&J’s Stelara® (ustekinumab), to be marketed as Fymskina (by Formycon) and Otulfi (by Fresenius). In March 2024 Formycon and Fresenius announced they reached a settlement with J&J regarding the commercialisation of FYB202 in Europe and Canada. This followed a US settlement in August 2023, enabling US launch of FYB202 “no later than 15 April 2024”.
Also in July 2024, Formycon announced enrolment of the first patient in its Phase III trial for FYB206 (pembrolizumab), biosimilar to MSD’s Keytruda®.
Three undisclosed biosimilar candidates are reportedly in development by Formycon, referred to as FYB208, FYB209 and FYB210.