Module 9 2021

22/03/2021

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THE EU REGULATORY SYSTEM

375 Words in EU Directives 7311 Words in US Act

Well-Established Medicinal Use Bibliographic

Similar Biological Medicinal Product Comparability

DIRECTIVE

2001/83/

Amendment Directive Dir. 2004/27/EC 30/10/05 Biosimilar legal concept 108 Words

Annex I Directive 2003/63/EC Biosimilar data requirements 267 words

EC

Generic Medicine (Formerly Essentially Similar) Bioequivalence

Mixed MAA. Bibliographic + Own Data

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THE US REGULATORY SYSTEM

375 Words in EU Directives

7311 Words in US Act in US

Section 351 of the Public Health Service Act (42 U.S.C. 262) amended by The Biological, Price Competition & Innovation Act of 2009

Synthetic peptides ≤ 100 amino acids, recombinant peptides ≤ 40 and non proteins LMW heparin* remain under FD&C Act

virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide ), or analogous product, or 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.

Federal Food, Drug, Cosmetic Act Act) 1938

Hormones (e.g. insulin, somatropin, FSH transition to PSA in March 2020

* = Biological in the EU

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