Formycon's FYB206, a Keytruda Biosimilar, Enters Clinical Development Amidst Strong Financial Results
Key Insights
Formycon (search)'s biosimilar candidate FYB206, referencing Keytruda, has commenced its clinical development program, including Phase I and Phase III studies, marking a significant milestone.
The company reported successful Q3 results with approvals for FYB202 (ustekinumab biosimilar) in the U.S. and Europe, triggering milestone payments from partner Fresenius Kabi.
FYB203 (aflibercept biosimilar) received a positive CHMP opinion for treating neovascular age-related macular degeneration (search) and other retinal diseases, expected to be finalized in January 2025.
Formycon (search) AG (FSE: FYB) has announced the initiation of clinical trials for FYB206, a biosimilar candidate for Keytruda (pembrolizumab), alongside reporting its financial results for the first nine months of 2024. The company's advancements in its biosimilar pipeline and solid financial performance underscore its position as a key player in the biosimilars market.
Clinical Development of FYB206
The clinical program for FYB206, a biosimilar candidate referencing Merck (search)'s Keytruda, has commenced with the enrollment of the first patient in a Phase I study in June 2024. This study aims to compare the pharmacokinetics, safety, and tolerability of FYB206 with Keytruda in patients with malignant melanoma (search). Concurrently, a Phase III study evaluating the safety and efficacy of FYB206 versus Keytruda in patients with non-small cell lung cancer (search) (NSCLC) began in July 2024. Analytical study results, published in Drugs in R&D, confirmed a high degree of similarity between FYB206 and the reference medicine, Keytruda.
Regulatory Successes for FYB202 and FYB203
Formycon (search) achieved regulatory milestones with the approval of FYB202 (ustekinumab biosimilar) by both the U.S. Food and Drug Administration (FDA) and the European Commission in September 2024. FYB202, to be marketed as Otulfi by Fresenius Kabi, is approved for treating severe inflammatory diseases, including Crohn's disease, moderate to severe plaque psoriasis (search), and active psoriatic arthritis (search). Fresenius Kabi is expected to launch Otulfi in the USA no later than February 22, 2025. Additionally, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of FYB203 (aflibercept biosimilar), to be marketed as AHZANTIVE and Baiama, for treating neovascular age-related macular degeneration (search) (nAMD), diabetic macular edema (search) (DME), diabetic retinopathy (search) (DR), and macular edema (search) secondary to retinal vein occlusion (RVO). The European Commission's final decision is anticipated in the second half of January 2025.
Market Performance of FYB201
FYB201 (ranibizumab), marketed as CIMERLI in the United States, has gained a significant market share, exceeding 40% of the U.S. ranibizumab market as of August 2024. In the United Kingdom, FYB201/ONGAVIA holds a dominant market position with over 80% market share based on indication-based market volume. FYB201 is now available in 20 countries worldwide.
Financial Highlights
For the first nine months of 2024, Formycon (search) Group reported revenues of approximately €41.1 million, in line with expectations. This includes income from FYB201 marketing and development services for partnered biosimilar candidates. Consolidated earnings before interest, taxes, depreciation, and amortization (EBITDA) amounted to approximately €-17.7 million, reflecting increased research and development costs. However, the adjusted Group EBITDA, which includes the earnings contribution from Bioeq AG (Formycon's 50% stake), amounted to €2.9 million.
Pipeline Expansion
Formycon (search) is expanding its biosimilar platform with candidates FYB208 and FYB209 in early development. Furthermore, FYB210, a new biosimilar candidate in the immunology field, has been initiated, targeting commercialization after 2030.
Leadership and Stock Exchange Uplisting
The management contract of CEO Dr. Stefan Glombitza has been extended until December 2027. Formycon (search) successfully uplisted to the Prime Standard of the Frankfurt Stock Exchange in November 2024, enhancing the company's visibility and transparency in the global capital markets.
Formycon (search) anticipates continued business progress in the fourth quarter, with revenues expected to be slightly higher than the average of the first three quarters. The milestone payments received from Fresenius Kabi for FYB202 approvals are expected to stabilize the company's cash position.