XTalks

NOVEMBER 6, 2024

This regulatory strategy leverages bioequivalence studies to expedite approval, positioning Gelteq’s gel as an alternative to traditional oral delivery forms. In the pharmaceutical segment, Gelteq advances its lead product — a gel-based pain management therapy — through the US Food and Drug Administration (FDA)’s 505(b)(2) pathway.

Drug Delivery 104

Drug Delivery Drugs Bioequivalency Bioavailability 104

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.

Production 52

Production Generic Drugs Drugs Bioequivalency 52

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.

Production 78

Production Insulin Branding Generic Drugs 78

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.

Marketing 52

Marketing FDA Approval Branding Production 52