The advent of biosimilars: Challenges and risks

Swiss Medical Weekly

Volumn 144, Issue , 2014, Pages

  Müller, Rüdiger ^a   Renner, Christoph ^b,c   Gabay, Cem ^d   Cassata, Giuseppe ^e   Lohri, Andreas ^f   Hasler, Paul ^g  

^a CANTONAL HOSPITAL ST GALLEN   (Switzerland)

^b Onkozentrum Hirslanden   (Switzerland)

^c OnkoZentrum Zürich   (Switzerland)

^d GENEVA UNIVERSITY HOSPITALS   (Switzerland)

^e Roche Pharma Schweiz AG   (Switzerland)

^f Kantonsspital Liestal   (Switzerland)

^g CANTONAL HOSPITAL AARAU   (Switzerland)

Author keywords

Approval process; Biosimilars; Extrapolation; Interchangeability; Manufacturing process; Monoclonal antibodies; Swissmedic; Switching

Indexed keywords

ANTINEOPLASTIC AGENT; BETA1A INTERFERON; BIOLOGICAL PRODUCT; BIOSIMILAR AGENT; EFALIZUMAB; HUMAN GROWTH HORMONE; IBRUTINIB; IDELALISIB; INFLIXIMAB; INSULIN; INTERFERON; MONOCLONAL ANTIBODY; OBINOTUZUMAB; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GLUCAN 1,4 ALPHA GLUCOSIDASE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT PROTEIN; RITUXIMAB; TRASTUZUMAB; UNCLASSIFIED DRUG;

BIOLOGICAL PHENOMENA AND FUNCTIONS CONCERNING THE ENTIRE ORGANISM; CANCER PATIENT; COST BENEFIT ANALYSIS; DRUG DESIGN; DRUG EFFICACY; DRUG MANUFACTURE; DRUG SAFETY; DRUG STRUCTURE; DRUG SURVEILLANCE PROGRAM; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNOGENICITY; KNOWLEDGE; MAMMAL CELL; MEDICINE; NONHUMAN; PATENT; PATIENT SAFETY; PROTEIN EXPRESSION; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; UNCERTAINTY; AMINO ACID SEQUENCE; CHEMISTRY; DRUG DEVELOPMENT; DRUG LEGISLATION; DRUG SUBSTITUTION; IMMUNOLOGY; PROTEIN CONFORMATION; SYNTHESIS;

AMINO ACID SEQUENCE; ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; DRUG DISCOVERY; DRUG SUBSTITUTION; HUMANS; LEGISLATION, DRUG; PROTEIN CONFORMATION;

EID: 84903835589     PISSN: 14247860     EISSN: 14243997     Source Type: Journal    
DOI: 10.4414/smw.2014.13980     Document Type: Review

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