Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensing partner Bioeq AG (“Bioeq”) confirm the planned timeline for resubmission of the Biologics License Application (“BLA”) for their Lucentis(R) biosimilar candidate FYB201 following a successful pre-BLA interaction with the U.S. Food and Drug Administration (FDA).
As announced in November 2020, the initial submission strategy of the Lucentis(R) biosimilar candidate FYB201 has been adjusted as part of a simplification of the approval procedure. With the optimization of the commercial supply chain, the approval for FYB201 will directly occur in a large commercial scale. In the context of the interaction with the FDA, the data requested by the authorities have been reviewed and the further procedure has been aligned. The BLA-submission is expected to be filed with the U.S. Food and Drug Administration on schedule during the first half of 2021. Submission to the European Medicines Agency (EMA) is expected to follow-up.
In addition to the approval in the United States of America and the countries of the European Union, Formycon and Bioeq are seeking approval of the biosimilar candidate to Lucentis(R) (ranibizumab) in other highly regulated territories such as Canada, Australia, the United Kingdom and Switzerland.
* Lucentis(R) 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.