Module 9 2024

05/09/2024

Biosimilar Regulation was Born in the EU

Quality guideline Revision (2012)

Directive 2003/63/EC

Reference: Updated from Alberto Ganan Jimenez & Brigitte Brake (May, 2011): Biosimilars in the European Union -regulatory perspectives, Kaula Lumpur, Malaysia

The Organisation for Professionals in Regulatory Affairs

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Definition of Biological Medicine

Annex 1 to Directive 2003/63/EC (3.2.1.1)

produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physicochemical-biological testing, together with the production process for its control

Section 351(i), PHSA, 42 U.S.C. § 262(i) a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, analogous product, protein (except any chemically synthesized polypeptide) and arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings

The Organisation for Professionals in Regulatory Affairs

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