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® 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® 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® is a registered trademark of Genentech Inc.
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.