Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced the start of a Phase I clinical trial comparing the pharmacokinetics, safety, and tolerability of FYB202 and the reference product Stelara® (USA / EU). Dosing of study subjects started last week.
FYB202 is being developed in a joint venture by Aristo Pharma GmbH and Formycon AG in which Aristo Pharma GmbH holds 75.1% and Formycon AG 24.9%. Bioeq GmbH is the sponsor of the clinical trial and is also responsible for the study design and clinical operation.
Provided successful completion of clinical Phase I and subsequent Phase III testing and timely regulatory approval, FYB202 can be launched after patent expiry of Stelara® (USA 09/2023; EU 07/2024).
* Stelara® is a registered trademark of Johnson & Johnson.
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of antibody-based COVID-19 compounds.
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2020, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. In 2019, global sales of biosimilars exceeded USD12 billion. Analysts estimate that this figure could rise to around USD 69 billion by 2025.