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Formycon Plans Ranibizumab Filings With Ustekinumab And Aflibercept In The Wings

 
• By Aidan Fry

Formycon will follow a US filing for ranibizumab before the end of this year with a European submission early in 2020 as it continues work on biosimilar ustekinumab and aflibercept.

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Formycon is gearing up to file its FYB201 ranibizumab biosimilar candidate for approval in the US and the EU • Source: Shutterstock

German biosimilars developer Formycon intends to file its FYB201 ranibizumab candidate with the US Food and Drug Administration by the end of this year after it and marketing partner Bioeq “successfully concluded” a pre-submission meeting with the agency in December 2018. A submission to the European Medicines Agency (EMA) is scheduled for the first quarter of 2020.

“If the submissions progress as planned, marketing authorization approvals in the US and the EU are expected in 2021,” commented Formycon, which will receive sales-dependent royalties from its global commercialization partner, the Zürich-based Bioeq joint venture between Poland’s

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