Biologics, Biosimilars & ATMPs

Biologic pathways, biosimilarity, interchangeability, and advanced therapy concepts

9 terms

A comparative analytical assessment showing a proposed biosimilar is highly similar to the reference product across critical quality attributes.

Advanced Therapy Medicinal Product(ATMP)

EU category including gene therapy medicinal products, somatic cell therapy medicinal products, and tissue engineered products, regulated under specific EU legislation.

Biosimilar

A biological product shown to be highly similar to an FDA-licensed reference product, notwithstanding minor differences in clinically inactive components, with no clinically meaningful differences in safety, purity, and potency.

Center for Biologics Evaluation and Research(CBER)

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Biologics, Biosimilars & ATMPs

Biologic pathways, biosimilarity, interchangeability, and advanced therapy concepts

9 terms

Analytical Similarity

A comparative analytical assessment showing a proposed biosimilar is highly similar to the reference product across critical quality attributes.

Advanced Therapy Medicinal Product(ATMP)

EU category including gene therapy medicinal products, somatic cell therapy medicinal products, and tissue engineered products, regulated under specific EU legislation.

Biosimilar

A biological product shown to be highly similar to an FDA-licensed reference product, notwithstanding minor differences in clinically inactive components, with no clinically meaningful differences in safety, purity, and potency.

Center for Biologics Evaluation and Research(CBER)

An FDA center responsible for regulating biological products such as vaccines, blood products, and many cell/gene therapies.

Gene Therapy

A therapeutic approach that introduces, removes, or alters genetic material within a patient’s cells to treat or prevent disease, often regulated as a biologic/ATMP.

Interchangeable Biosimilar

A biosimilar that meets additional requirements such that it may be substituted for the reference product at the pharmacy (subject to state law) without prescriber intervention.

Potency Assay

A quantitative measure of biological activity of a product, critical for biologics/ATMPs and often closely linked to mechanism of action and clinical performance.

351(k) Pathway(351(k))

The US biosimilar licensure pathway under the Public Health Service Act for biosimilar and interchangeable biological products.

Viral Vector

A virus engineered to deliver genetic material into cells, commonly used in gene therapies and requiring specific CMC controls for safety and potency.