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Formycon AG / Key word(s): Regulatory Admission/Statement
Formycon informs about the current Status of the BLA Review Process of the Lucentis(R)* Biosimilar Candidate FYB201
04-Feb-2020 / 22:02 CET/CEST
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Ad-Hoc announcement // Feb 4, 2020 // 22:00 CET
Formycon informs about the current Status of the BLA Review Process of the Lucentis(R)* Biosimilar Candidate FYB201
Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensing partner Bioeq AG ("Bioeq") announce today, that the U.S. Food and Drug Administration (FDA) has requested additional data as part of the review process of the Biologics License Application (BLA) for the Lucentis(R) biosimilar candidate FYB201, submitted by Bioeq in December 2019.
Following the request of a national European health authority, the drug substance contract manufacturer has moved a piece of processing equipment to a different location within the same site after the production of the FYB201 drug substance qualification batches was completed. As a result of the move, the FDA has requested additional manufacturing data for the equipment in its new location in the context of its review of the BLA application. Formycon and Bioeq believe that it will take approximately four months to generate this additional data to comply with the FDA's request. Therefore Bioeq has decided to withdraw its BLA application for the Lucentis(R) biosimilar candidate, provide the requested data and resubmit the application thereafter, which may delay the approval of the BLA. These additional requests are not related to the quality of the drug substance or other product characteristics.
* Lucentis(R) is a registered trademark of Genentech Inc.
About Formycon:
Formycon is a leading, independent developer of high-quality follow-on products for biopharmaceutical medicines known as 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.
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. While the global market for biosimilars is currently more than USD 5.0 billion, industry experts expect this figure to grow up to USD 30 billion by the year 2025.
Contact Formycon AG:
Sabrina Müller
Corporate Communications and Investor Relations
Fraunhoferstr. 15
82152 Martinsried/Planegg/Germany
phone +49 (0) 89 - 86 46 67 149
fax + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com // 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.
04-Feb-2020 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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