Biosimilars or semi-similars?

Nature Biotechnology

Volumn 33, Issue 1, 2015, Pages 19-20

  Schellekens, Huub ^a   Moors, Ellen ^a  

^a UTRECHT UNIVERSITY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; BIOSIMILAR AGENT; HUMAN GROWTH HORMONE; INFLIXIMAB; MONOCLONAL ANTIBODY; RECOMBINANT ERYTHROPOIETIN; TUMOR NECROSIS FACTOR ALPHA;

ANKYLOSING SPONDYLITIS; CANCER PATIENT; CLINICAL STUDY; CLINICAL TRIAL (TOPIC); CROHN DISEASE; DEVELOPED COUNTRY; DRUG APPROVAL; DRUG INDUSTRY; DRUG MARKETING; EUROPE; EUROPEAN MEDICINES AGENCY; EXTRAPOLATION; HIGH RISK PATIENT; HUMAN; IMMUNOGENICITY; IN VITRO STUDY; LETTER; LOW RISK PATIENT; MATHEMATICAL ANALYSIS; NOMENCLATURE; PATHOGENESIS; PATIENT SAFETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PSORIASIS; RHEUMATOID ARTHRITIS; THERAPEUTIC EQUIVALENCE;

EID: 84964211552     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt.3083     Document Type: Letter

References (5)

1. Dorey, E. Nat. Biotechnol. 31, 774 (2013).
2. European Medicines Agency. CHMP Assessment Report for Filgrastim Hexal. (no. EMEA/CHMP/651324/2008) http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Public-assessment-report/human/000918/WC500022471.pdf (2008).
3. European Medicines Agency. European Public Assessment Report for Binocrit. http://www. ema.europa.eu/docs/en-GB/document-library/EPAR-Scientific-Discussion/human/000725/WC500053615.pdf (2007).
4. European Medicines Agency. CHMP Assessment Report for Remsima. (no. EMA/CHMP/589317/2013) http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Public-assessment-report/human/002576/WC500151486.pdf (2013).
5. European Medicines Agency. CHMP Draft Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. (no. CHMP EMEA/CHMP/BMWP/42832/2005, rev. 1) http://www.ema. europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003920.pdf (2006).