February 5, 2020 / 6:31 AM / 18 days ago

BRIEF-Formycon: FDA Requests Additional Data For Lucentis(R)Biosimilar Candidate FYB201

Feb 5(Reuters) - FORMYCON AG

* SAID ON TUESDAY FDA HAS REQUESTED ADDITIONAL DATA AS PART OF REVIEW PROCESS OF BIOLOGICS LICENSE APPLICATION (BLA) FOR LUCENTIS(R)BIOSIMILAR CANDIDATE FYB201

* BELIEVES IT WILL TAKE ABOUT FOUR MONTHS TO GENERATE ADDITIONAL DATA TO COMPLY WITH FDA’S REQUEST

* LICENSING PARTNER BIOEQ TO WITHDRAW BLA APPLICATION FOR THE LUCENTIS(R) BIOSIMILAR CANDIDATE, PROVIDE REQUESTED DATA AND RESUBMIT APPLICATION THEREAFTER, WHICH MAY DELAY APPROVAL OF BLA

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Further company coverage: (Gdansk Newsroom)

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