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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

Development

Development Production Immune Response Licensing

Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

FEBRUARY 8, 2021

Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product. If the FDA licenses an interchangeable, that means that switching between the interchangeable and the reference doesn’t increase the safety risk or decrease the effectiveness compared to using the reference only,” says Brahme.

Production

Production Insulin Branding Generic Drugs

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

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