Formycon Shifts Strategy On US Lucentis Biosimilar
As First Patient Dosed In Ustekinumab Phase III Studies
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.”
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The US FDA has accepted for review the CHS-201 Lucentis biosimilar product developed by Formycon/Bioeq that is to be sold in the US by Coherus BioSciences, shortly after approving the first ranibizumab biosimilar to treat wet age-related macular degeneration.
Launch planning is underway for the Lucentis biosimilar that Coherus BioScienes has in-licensed in the US from Formycon and Bioeq, the US-based firm has revealed, as the eye-disease biologic was submitted to the US Food and Drug Administration.
Formycon and partner Bioeq have offered further details on timing for the submission of their FYB201 proposed ranibizumab biosimilar version of Lucentis in Europe, the US and elsewhere.