title: The advent of biosimilars: challenges and risks.
abstract: Biosimilars represent a new class of medicinal products that will have significant impact on clinical use. They are identical on an amino acid sequence level to existing reference biopharmaceutical products (originals). However, they may exhibit differences on a protein level. This paper provides a brief overview of biosimilar development and describes the risk and challenges that should be considered during the admission of biosimilars into the clinic.
authors.affiliation: Kantonsspital St. Gallen, Switzerland.
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Müller
authors.affiliation: Onkozentrum Hirslanden, Zürich, and Onkozentrum Zürich, Switzerland.
authors.forename: Christoph
authors.initials: C
authors.lastname: Renner
authors.affiliation: Hôpitaux universitaires de Genève, Genève, Switzerland.
authors.forename: Cem
authors.initials: C
authors.lastname: Gabay
authors.affiliation: Roche Pharma (Schweiz) AG, Reinach (BL), Switzerland.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Cassata
authors.affiliation: Kantonsspital Baselland, Liestal, Switzerland.
authors.forename: Andreas
authors.initials: A
authors.lastname: Lohri
authors.affiliation: Kantonsspital Aarau, Aarau, Switzerland.
authors.forename: Paul
authors.initials: P
authors.lastname: Hasler
mesh_terms: D000595:Amino Acid Sequence; D000911:Antibodies, Monoclonal / Q000737:chemistry / Q000276:immunology; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000138:chemical synthesis* / Q000737:chemistry; D055808:Drug Discovery; D057915:Drug Substitution; D006801:Humans; D007880:Legislation, Drug; D011487:Protein Conformation
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals