Matthews, Duncan --- "Exclusivity for biologics" [2017] ELECD 807; in Matthews, Duncan; Zech, Herbert (eds), "Research Handbook on Intellectual Property and the Life Sciences" (Edward Elgar Publishing, 2017) 104

Book Title: Research Handbook on Intellectual Property and the Life Sciences

Editor(s): Matthews, Duncan; Zech, Herbert

Publisher: Edward Elgar Publishing

ISBN (hard cover): 9781783479443

Section: Chapter 6

Section Title: Exclusivity for biologics

Author(s): Matthews, Duncan

Number of pages: 15

Abstract/Description:

Biologics, a relatively new phenomenon in the life sciences, are large molecule therapies that contain proteins derived from living plant and animal cells, bacteria and viruses. Examples of biologics are hormones such as insulin, enzymes to speed up chemical reactions, blood factors to regulate blood clotting, antibodies to support the immune system, and vaccines and advanced therapies including cell, gene and tissue therapy products. Biologics differ from small molecule medicines, which involve fewer process steps than the manufacture of biologics. While small molecule medicines can be copied into generic medicines that are an exact copy of the active pharmaceutical ingredient, because biologics have been developed using living organisms, it is impossible to achieve an exact copy of the originator medicine.