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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. BLA process (CBER).

Development

Development Production Immune Response Licensing

Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

FEBRUARY 8, 2021

While there are currently six biosimilars for AbbVie’s Humira (adalimumab) that have been approved by the regulator, the company’s patents prevent biosimilars from being launched until 2023. The regulator allows biosimilars to show slight differences in clinically inactive components of a product.

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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