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.