Zydus receives USFDA review for FYB206 biosimilar
The BLA acceptance marks the first publicly announced Keytruda biosimilar filing. Formycon earned a milestone payment from Zydus under their exclusive agreement.
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Global pharmaceutical company
zyduslife.comLast updated
In short: Zydus secured USFDA approvals and pipeline milestones while Q1 profit fell despite revenue growth.
The BLA acceptance marks the first publicly announced Keytruda biosimilar filing. Formycon earned a milestone payment from Zydus under their exclusive agreement.
The trial met its primary endpoint. Results will be presented at upcoming scientific meetings and submitted for publication.
The unaudited consolidated net profit after tax was INR 9,398 million, with total income from operations of INR 80,170 million for the quarter.
Net profit declined 35.9% YoY, EBITDA margin fell to 24.1%, while acquisitions and a Sri Lanka JV were announced.
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