Pharma in Brief
FEBRUARY 8, 2024
For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”. According to the Notice, the alternate CRP is preferably another generic drug that has demonstrated bioequivalence with the “Dormant” innovative drug.
Delveinsight
FEBRUARY 5, 2021
Rather, the bioequivalence studies were performed using the 150 mg strength; and the data was extrapolated to the higher dose. Two doses, bupropion XL 15 mg and bupropion XL 300 were approved. Since the higher dose was associated with the risks of seizures, the FDA granted a waiver in its testing.
XTalks
FEBRUARY 8, 2021
Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product. MYTH: Clinical pharmacology studies of biosimilars aim to establish safety and effectiveness.
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