FORMYCON INFORMS ABOUT THE MODIFIED BLA-SUBMISSION STRATEGY FOR ITS LUCENTIS(R)* BIOSIMILAR-CANDIDATE FYB201
Munich ? Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensing partner Bioeq AG (?Bioeq?) announced today that the Biologics License Application (BLA) resubmission strategy for FYB201 has been adjusted.
The approval for FYB201 will be requested directly for a large commercial scale. Formycon and Bioeq are in close coordination with the U.S. Food and Drug Administration (FDA). Through the revised submission strategy, Formycon and Bioeq expect a simplification of the approval procedure. The modified submission dossier is expected to be filed with the FDA in the first half of 2021. The adjustment of the regulatory strategy in the course of optimizing the commercial supply chain is not expected to have any impact on the timing of the anticipated launch of FYB201 in the US and European Union countries.
* Lucentis(R) is a registered Trademark of Genentech Inc.
End of Ad Hoc Announcement
About Formycon:
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.
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. In 2019, global sales of biosimilars exceeded USD12 billion. Analysts estimate that this figure could rise to around USD 69 billion by 2025.
Press & IR Contact
Sabrina M?ller
Senior Manager Corporate Communications and
Investor Relations
T + 49 89 86 46 67 149
F + 49 89 86 46 67 110
sabrina.mueller@formycon.com
Formycon AG
Fraunhoferstr. 15
82152 Planegg/Martinsried
Germany
www.formycon.com
Disclaimer:
This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here.
Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful.
Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated.
This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended.
This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.
