Vision & Mission
Helping patients with safe, effective biologic drugs
Our aim and vision is to enable broad access to high quality, highly competitive biopharmaceuticals for the treatment of serious diseases.
Medicines of the future
Biosimilars are the drugs of the future. Through their proven efficacy, cost efficiency and high standard of quality, Biosimilar medicines are already making a major contribution towards enabling patient access to effective medical treatments.
Through our biosimilars, we will help not only patients around the world but also help to ease the financial strains on the world’s healthcare systems.
“Biological medicines are … complex and can be very expensive and time consuming to develop. This can limit patients’ access to such medicines, and can make it difficult for the healthcare system to afford them. Biosimilar medicines can improve patient access to such treatments.”
European Commission, Biosimilar Medicines: Information for Patients, 2016
Profitable and sustainable growth
We are already an important market player in the biosimilars segment. Our ambition is to further strengthen this position and to become an internationally significant player in the sense of a fully integrated and globally operating company in the growth segment of biosimilars. Based on the transaction in 2022 with ATHOS KG, Formycon expands its radius of action and thus accelerates sustainable growth by increasing future revenues of biosimilar candidates and a continuous expansion of the development pipeline.
Our late-stage biosimilar candidates focus on the “third wave” of biosimilars, meaning follow-on drugs to compete with established blockbuster biopharmaceuticals for which patent protection will begin expiring from the year 2020 onwards. Because Formycon began targeting these products at an early stage, the company is now uniquely positioned to lead the way into these new markets. Preclinical pipeline projects such as FYB206 and other potential biosimilar candidates target reference drugs whose legal protection periods expire at a later date.
“The market is well positioned to achieve a robust growth in the coming decade … Based on a very comprehensive analysis, we have projected the market to be worth USD 32 billion worldwide by 2025.”
Research and Markets,Global Biosimilars Market Report, 2015 – 2025
Strong pipeline
Building on the specialized expertise and long experience of our team, as well as our successful established track record in biosimilar development, we are able to evaluate further potential and promising biosimilar candidates for our pipeline.
Because Formycon spans the entire value chain – from early analysis to technical-pharmaceutical development and clinical trials, all the way through to preparation and submission of dossiers for regulatory approval – we are able to offer our partners a complete, end-to-end drug development concept.
We currently have a total of six biosimilar candidates. FYB201 is already approved in the US, the EU and the UK. FYB202 and FYB203 are at a very advanced stage of clinical development. FYB206 is a preclinical biosimilar candidate, FYB208 and FYB209 are both in an early development stage.
“In the coming year, biosimilars will play an increasingly important role in the treatment of serious diseases ... and in keeping our health care system affordable.”
German Federal Ministry of Health, Report on Results of Pharmaceutical Dialog, 2016
Latest news
September 29, 2023
Formycon and Fresenius Kabi announce European Medicines Agency Acceptance of the Marketing Authorization Application for FYB202, an Ustekinumab Biosimilar Candidate
Formycon AG and its commercialization partner Fresenius Kabi today announced that the European Medicines Agency (“EMA”) has accepted the Marketing Authorization Application (“MAA”) for FYB202, a proposed biosimilar candidate to Stelara®.
August 30, 2023
Formycon reports successful first half of 2023
Formycon AG today published the financial results and the corporate development of Formycon Group for the first half of 2023.
August 29, 2023
Formycon announces File Acceptance for FYB203, a biosimilar candidate to Eylea® (aflibercept), by the U.S. Food and Drug Administration (FDA)
Formycon AG and its license partner Klinge Biopharma GmbH announce that the U.S. Food and Drug Administration has accepted the biologics license application for FYB203, a biosimilar candidate to Eylea®, for review
¹ Lucentis is a registered trademark of Genentech, Inc
² Stelara is a registered trademark of Johnson & Johnson
³ Eylea is a registered trademark of Regeneron Pharmaceuticals, Inc.
4 Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.