C K Schneider1,2,3, M Weise4,5. 1. Abteilung Arzneimittelzulassung und -Zugänglichkeit, Danish Health and Medicines Authority, Axel Heides Gade 1, 2300, Kopenhagen, Dänemark. ckschneider@gmx.de. 2. Biosimilar Medicinal Products Working Party (BMWP), Europäische Arzneimittelagentur, London, UK. ckschneider@gmx.de. 3. TwincoreZentrum für Experimentelle und Klinische Infektionsforschung, Hannover, Deutschland. ckschneider@gmx.de. 4. Biosimilar Medicinal Products Working Party (BMWP), Europäische Arzneimittelagentur, London, UK. 5. Fachgebiets Diabetes mellitus/Kardiovaskuläres System, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Deutschland.
Abstract
BACKGROUND: Biosimilars are currently a hot topic and there are many unsolved questions, misunderstandings and sometimes considerable uncertainty, especially among clinicians and patients. Regulatory agencies, such as the European Medicines Agency (EMA) issue guidelines for the development and approval of biosimilars, which are based on scientific principles. OBJECTIVE: This article addresses some of the frequently noted misunderstandings and misperceptions. For example, why biosimilars are (or can only be) "similar" but not "identical" compared to the original pharmaceutical product, and aspects, such as the pharmaceutical quality of biosimilars, immunogenicity and the approval process for biosimilars are highlighted.
BACKGROUND: Biosimilars are currently a hot topic and there are many unsolved questions, misunderstandings and sometimes considerable uncertainty, especially among clinicians and patients. Regulatory agencies, such as the European Medicines Agency (EMA) issue guidelines for the development and approval of biosimilars, which are based on scientific principles. OBJECTIVE: This article addresses some of the frequently noted misunderstandings and misperceptions. For example, why biosimilars are (or can only be) "similar" but not "identical" compared to the original pharmaceutical product, and aspects, such as the pharmaceutical quality of biosimilars, immunogenicity and the approval process for biosimilars are highlighted.
Entities:
Keywords:
Approval; European Medicines Agency; Guidelines; Original formulation; Regulatory agencies
Authors: Nicole Casadevall; Joelle Nataf; Beatrice Viron; Amir Kolta; Jean-Jacques Kiladjian; Philippe Martin-Dupont; Patrick Michaud; Thomas Papo; Valerie Ugo; Irene Teyssandier; Bruno Varet; Patrick Mayeux Journal: N Engl J Med Date: 2002-02-14 Impact factor: 91.245
Authors: Leon A G J M van Aerts; Karen De Smet; Gabriele Reichmann; Jan Willem van der Laan; Christian K Schneider Journal: MAbs Date: 2014 Impact factor: 5.857