Module 9 2021

22/03/2021

EVOLVING VIEWS

Whereas previously FDA required extensive clinical data (many 100s) for products such as filgrastim, pegfilgrastim, insulin and other non-glycosylated proteins with measurable relevant PD effects Now PD data in healthy subjects and immunogenicity adequate ● Coherus PegFilgrastim – Entire program in healthy volunteers – Single dose PK/PD study – Immunogenicity – two doses in ~300 patients – Not sure if design discussed with FDA

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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

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