title: Biosimilars: what clinicians should know.
abstract: Biosimilar medicinal products (biosimilars) have become a reality in the European Union and will soon be available in the United States. Despite an established legal pathway for biosimilars in the European Union since 2005 and increasing and detailed regulatory guidance on data requirements for their development and licensing, many clinicians, particularly oncologists, are reluctant to consider biosimilars as a treatment option for their patients. Major concerns voiced about biosimilars relate to their pharmaceutical quality, safety (especially immunogenicity), efficacy (particularly in extrapolated indications), and interchangeability with the originator product. In this article, the members and experts of the Working Party on Similar Biologic Medicinal Products of the European Medicines Agency (EMA) address these issues. A clear understanding of the scientific principles of the biosimilar concept and access to unbiased information on licensed biosimilars are important for physicians to make informed and appropriate treatment choices for their patients. This will become even more important with the advent of biosimilar monoclonal antibodies. The issues also highlight the need for improved communication between physicians, learned societies, and regulators.
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany. martina.weise@bfarm.de
authors.forename: Martina
authors.initials: M
authors.lastname: Weise
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Bielsky
authors.forename: Karen
authors.initials: K
authors.lastname: De Smet
authors.forename: Falk
authors.initials: F
authors.lastname: Ehmann
authors.forename: Niklas
authors.initials: N
authors.lastname: Ekman
authors.forename: Thijs J
authors.initials: TJ
authors.lastname: Giezen
authors.forename: Iordanis
authors.initials: I
authors.lastname: Gravanis
authors.forename: Hans-Karl
authors.initials: HK
authors.lastname: Heim
authors.forename: Esa
authors.initials: E
authors.lastname: Heinonen
authors.forename: Kowid
authors.initials: K
authors.lastname: Ho
authors.forename: Alexandre
authors.initials: A
authors.lastname: Moreau
authors.forename: Gopalan
authors.initials: G
authors.lastname: Narayanan
authors.forename: Nanna A
authors.initials: NA
authors.lastname: Kruse
authors.forename: Gabriele
authors.initials: G
authors.lastname: Reichmann
authors.forename: Robin
authors.initials: R
authors.lastname: Thorpe
authors.forename: Leon
authors.initials: L
authors.lastname: van Aerts
authors.forename: Camille
authors.initials: C
authors.lastname: Vleminckx
authors.forename: Meenu
authors.initials: M
authors.lastname: Wadhwa
authors.forename: Christian K
authors.initials: CK
authors.lastname: Schneider
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000209:etiology; D004502:Education, Medical, Continuing; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D010820:Physicians; D011364:Professional Practice / Q000639:trends
chemical_list: D059451:Biosimilar Pharmaceuticals