Advair Bioequivalence Guidance Falls Short of GSK’s Requests
This article was originally published in The Pink Sheet Daily
FDA’s draft guidance requires clinical study but sets a lower bar to generics of GSK’s blockbuster asthma and COPD treatment than company proposed; standards appear poised for warm reception from generic challengers.
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The Morgan Stanley Healthcare Conference attracted top management from big pharma, biotech and specialty firms, with Sanofi’s Elias Zerhouni commenting on the company’s strategy in Gaucher’s disease and Mylan expressing confidence in its ability to deliver on a generic Advair that meets FDA’s newly-issued proposed standards for substitutability.