Shared First Interchangeable Biosimilar Exclusivity May Be Allowed Under US FDA User Fee Bill
Legislation in development also could create an option for tentative approval of interchangeable biosimilars.
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Pfizer expects to make significant strides in the adalimumab market once it launches its Humira biosimilar late next year, but may not be able to enjoy its anticipated interchangeability designation until 2024.
Federal court decision said the FDA cannot grant orphan exclusivity for subpopulations of a disease, which agency officials fear could damage pediatric rare disease drug development.
Rep. Dunn’s idea would be a return to prior agency practice; the documents are currently considered exempt from disclosure.