DGAP-News Formycon confirms BLA-Submission Strategy and Timeline for its Lucentis(R)* Biosimilar-Candidate FYB201 following consultation with the FDA
DGAP-News: Formycon AG / Key word(s): Miscellaneous/Regulatory Admission
Press Release // March 1, 2021
Formycon confirms BLA-Submission Strategy and Timeline for its Lucentis(R)* Biosimilar-Candidate FYB201 following consultation with the FDA
- Pre-BLA-interaction with U.S. Food and Drug Administration (FDA) confirms planned resubmission in first half of 2021
- Submission of the marketing authorization to the European Medicines Agency (EMA) in immediate consequence
- Submission for other highly regulated territories in preparation
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.