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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

As biologics have the reputation of being expensive due to their complex nature and production, biosimilars have the ability to improve market access to patients and payors who would otherwise be unable to afford these drugs. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed.

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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