FDA’s Interchangeability Improvements Impress Industry
Using comparator biologics not licensed in the US is foreseen in final FDA interchangeability guidance, shifting the agency’s previous stance on biosimilars.
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With a US filing for interchangeable infliximab scheduled for next year, Nichi-Iko is lining up a launch of etanercept in Japan as it seeks alliances to broaden its biosimilars pipeline.
Sandoz, which used an EU-approved comparator in the switch study for its biosimilar Erelzi, might have to redo the trial in light of FDA’s draft guidance.
Germany’s off-patent industry association, Pro Generika, is finding ample support for its position that by awarding tender contracts to exclusive suppliers, health insurance funds are contributing to drug shortages in the country.