Extrapolated Biosimilar Indications Won't Get More US Post-Marketing Requirements
This article was originally published in PharmAsia News
Biosimilars will have the same pharmacovigilance expectations as innovator biologics in the US despite the lack of clinical data for some extrapolated indications.
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Celltrion is not seeking interchangeable status, but it had data on a single transition from EU-approved Remicade; however, FDA's advisors said data on multiple switches between products would more accurately reflect real-world clinical practice.
Several fees for prescription drug, generic drug, and biosimilar applications are set to increase, although some also will drop.
The group will be called the Office of Therapeutic Products, but needs more people to handle its increasing workload.