Similar biological medicinal products containing recombinant human growth hormone: European regulation

Hormone Research

Volumn 69, Issue 1, 2007, Pages 14-21

  Pavlovic, Mira ^a   Girardin, Elizabeth ^a   Kapetanovic, Liliana ^a   Ho, Kowid ^a   Trouvin, Jean Hugues ^a  

^a AFSSAPS   (France)

Author keywords

Similar biological medicinal products, comparability; Somatropins

Indexed keywords

HUMAN GROWTH HORMONE;

ANTIGENICITY; DRUG ACTIVITY; DRUG EFFICACY; DRUG QUALITY; DRUG SAFETY; GROWTH HORMONE DEFICIENCY; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; NONHUMAN; PRIORITY JOURNAL; RISK ASSESSMENT; RISK MANAGEMENT; SHORT SURVEY; TREATMENT OUTCOME;

BIOLOGICAL PRODUCTS; DRUG APPROVAL; EUROPEAN UNION; GROWTH HORMONE; HUMAN GROWTH HORMONE; HUMANS; LEGISLATION, DRUG;

EID: 37249013778     PISSN: 03010163     EISSN: None     Source Type: Journal    
DOI: 10.1159/000111790     Document Type: Short Survey

References (28)

1. Directive 2004/27/CE du Parlement Européen et du Conseil, du 31 mars 2004;Directive 2001/83/EC, as amended by Directives 2003/63/EC and 2004/27/EC.
2. Guideline on Similar Biological Medicinal Products. CHMP/437/04 (CHMP adopted September 2005).
3. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues. EMEA/CHMP/BWP/49348/05 (CHMP adopted February 2006).
4. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. EMEA/CHMP/42832/05 (CHMP adopted February 2006).
5. Annex Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues - Guidance on Similar Medicinal Products Containing Somatropin. EMEA/CHMP/94528/05 (CHMP adopted February 2006).
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