Formycon AG
Cornelius Viehweg is a seasoned regulatory affairs professional with extensive experience in managing regulatory CMC for biopharmaceutical products, including mAb biosimilars at Formycon AG. Currently serving as Senior Manager Regulatory Affairs Project Coordination, Cornelius leads multiple matrix teams and coordinates submissions to major regulatory authorities globally. Previous roles include Global Regulatory Affairs CMC Manager at BioNTech SE and Manager of Global Regulatory Affairs CMC at CSL Behring, where strategic oversight and change control processes were key responsibilities. Early career experience includes implementing quality compliance systems at Getinge. Cornelius holds a Master of Science in Virology from The Philipp University of Marburg and a Bachelor of Science in Biology from FAU Erlangen-Nürnberg.
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Formycon AG
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Who we are 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 a COVID-19 drug FYB207 About Biosimilars: 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. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion. Contact: Formycon AG Fraunhoferstr. 15 82152 Martinsried/Planegg Germany phone +49 (0) 89 - 86 46 67 100 fax + 49 (0) 89 - 86 46 67 110 info@formycon.com