Biosimilars: Initial excitement gives way to reality

Nature Reviews Drug Discovery

Volumn 5, Issue 7, 2006, Pages 535-536

  Belsey, Mark J ^a   Harris, Laura M ^a   Das, Romita R ^a   Chertkow, Joanna ^a  

^a Datamonitor Healthcare   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; HUMAN GROWTH HORMONE; MONOCLONAL ANTIBODY; NEW DRUG; RECOMBINANT DNA; RECOMBINANT PROTEIN;

ARTICLE; CELL CULTURE; COMPETITION; COST CONTROL; DRUG APPROVAL; DRUG EFFICACY; DRUG FORMULARY; DRUG MARKETING; DRUG QUALITY; DRUG RESEARCH; DRUG SAFETY; EUROPE; EUROPEAN UNION; FINANCIAL MANAGEMENT; FOOD AND DRUG ADMINISTRATION; HUMAN; LICENCE; PATENT; PATIENT CARE; PRIORITY JOURNAL; UNITED STATES;

BIOLOGICAL PRODUCTS; DRUG APPROVAL; DRUGS, GENERIC; MARKETING; RECOMBINANT PROTEINS;

EID: 33745663466     PISSN: 14741776     EISSN: 14741784     Source Type: Journal    
DOI: 10.1038/nrd2093     Document Type: Article

References (7)

1. Schellekens, H. How similar do 'biosimilars' need to be? Nature Biotechnol. 22, 1357-1359 (2004).
2. Sheridan, C. First generic biologics finally approved. Nature Rev. Drug Discov. 5, 445 (2006).
3. Dove, A. Betting on biogenerics. Nature Biotechnol. 19, 117-120 (2001).
4. EMEA. Biotech medicines: First biosimilar drug on EU market. European Commission. Press release [online], (2006).
5. Sandoz, Inc. Sandoz gets precedent-setting US approval for Omnitrope® as first follow on version of a previously approved recombinant biotechnology drug. Press release [online], (2006).
6. EMEA/CHMP. Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues [online], (2005).
7. EMEA/CHMP. Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Quality Issues (2005).