title: MS in the analysis of biosimilars.
abstract: Biologic drugs are forming a larger and expanded part of the therapeutic drug market. The top ten best-selling drugs are currently a mix of small and large molecules, but it is expected that biologics will soon represent a large majority of the top-selling drugs. These drugs have a high degree of complexity and must be analyzed using information-rich analytical techniques to fully characterize the drug. Thus, biosimilar copies of these innovator drugs must also be intensively analyzed to ensure they have comparable analytical profiles. In this article we discuss the regulatory requirements for introducing a follow-on biologic, or biosimilar, drug on the market, how analytics in general can be used to reduce the need for comprehensive clinical trials, and how MS in particular is becoming increasingly valuable in these analyses.
authors: Chris A
authors: CA
authors: Singleton
mesh_terms: D000595:Amino Acid Sequence; D061067:Antibodies, Monoclonal, Humanized / Q000737:chemistry / Q000378:metabolism; D059451:Biosimilar Pharmaceuticals / Q000737:chemistry*; D013058:Mass Spectrometry / Q000379:methods*; D008969:Molecular Sequence Data; D059748:Proteolysis; D012926:Social Control, Formal; D000068878:Trastuzumab; D014357:Trypsin / Q000378:metabolism
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D059451:Biosimilar Pharmaceuticals; D014357:Trypsin; D000068878:Trastuzumab