title: Biosimilars, generic versions of the first generation of therapeutic proteins: do they exist?
abstract: This contribution describes the present regulatory status in the EU of biosimilars, the generic versions of the first generation of therapeutic proteins. It points out why and where recombinant protein molecules and low-molecular-weight drugs differ in their behaviour and why biosimilars should be handled differently than generic low-molecular-weight drugs. This information is important for practitioners (pharmacists and physicians) while selecting the best supplier of a therapeutic protein.
authors.affiliation: Faculty of Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
authors.forename: Daan
authors.initials: D
authors.lastname: Crommelin
authors.forename: Theresa
authors.initials: T
authors.lastname: Bermejo
authors.forename: Marco
authors.initials: M
authors.lastname: Bissig
authors.forename: Jaak
authors.initials: J
authors.lastname: Damiaans
authors.forename: Irene
authors.initials: I
authors.lastname: Krämer
authors.forename: Patrick
authors.initials: P
authors.lastname: Rambourg
authors.forename: Giovanna
authors.initials: G
authors.lastname: Scroccaro
authors.forename: Borut
authors.initials: B
authors.lastname: Strukelj
authors.forename: Roger
authors.initials: R
authors.lastname: Tredree
authors.forename: Claudio
authors.initials: C
authors.lastname: Ronco
mesh_terms: D000917:Antibody Formation; D001702:Biopharmaceutics / Q000331:legislation & jurisprudence; D004355:Drug Stability; D016568:Drugs, Generic / Q000737:chemistry; D006801:Humans; D015394:Molecular Structure; D008970:Molecular Weight; D004364:Pharmaceutical Preparations; D011994:Recombinant Proteins / Q000737:chemistry*
chemical_list: D016568:Drugs, Generic; D004364:Pharmaceutical Preparations; D011994:Recombinant Proteins