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Formycon Shifts Strategy On US Lucentis Biosimilar

As First Patient Dosed In Ustekinumab Phase III Studies

 
• By Dean Rudge

Formycon has announced a change of strategy for the FYB201 biosimilar ranibizumab candidate being developed with Bioeq. Both firms insist the change is “not expected to have any impact on the timing of the anticipated launch of FYB201 in the US and EU countries.”

Sand running through the bulbs of an hourglass measuring the passing time in a countdown to a deadline, on a dark background with copy space.
The required pre-filing meetings with FDA are now expected to take place in early 2021 • Source: Shutterstock

Formycon and licensing partner Bioeq have announced they will seek US Food and Drug Administration approval for the firms’ FYB201 biosimilar ranibizumab candidate “directly for a large commercial scale,” through a revised submission strategy of the biologics license application that is expected to simplify the approval procedure.

Nevertheless, the change of direction represents yet another delay in filing, with Bioeq having filed

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