One interchangeable biosimilar should not be substituted for another in the US, and US Food and Drug Administration (FDA) guidance should reflect that, several biologics originators argued during an FDA public hearing on biologic competition and innovation. The same point was echoed by the originator-backed Alliance for Safe Biologic Medicines (ASBM).
Originators query switching
One interchangeable biosimilar should not be substituted for another in the US, and US Food and Drug Administration (FDA) guidance should reflect that, several biologics originators argued during an FDA public hearing on biologic competition and innovation. The same point was echoed by the originator-backed Alliance for Safe Biologic Medicines (ASBM).
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Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.
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Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.
Echoing wider sentiments in the biosimilar and generic drug industry, the IGBA has warned of the potential consequences of mercantilist tariffs on the global drug supply and their impact on industry and patients.
Alvotech and Advanz have announced a UK MHRA filing acceptance for their partnered AVT23 proposed biosimilar to Xolair (omalizumab).