Biosimilar somatropin: Myths and facts

Hormone Research

Volumn 69, Issue 1, 2007, Pages 29-30

  Hoppe, W ^a   Berghout, A ^a  

^a Sandoz Pharma Ltd   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN GROWTH HORMONE;

BIOTECHNOLOGY; HEALTH PRACTITIONER; IMMUNE RESPONSE; IMMUNOGENICITY; MEDICINAL PLANT; NOTE; PRIORITY JOURNAL; RISK MANAGEMENT;

BIOLOGICAL PRODUCTS; DRUG INDUSTRY; EUROPE; GROWTH HORMONE; HUMANS;

EID: 37249029091     PISSN: 03010163     EISSN: None     Source Type: Journal    
DOI: 10.1159/000111792     Document Type: Note

References (8)

1. Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. Official Journal L159, 27/6/2003, pp 46-94.
2. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal L136, 30/4/2004, p 34-57.
3. Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Quality Issues (EMEA/CHMP/49348/05).
4. Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues (EMEA/CHMP/42832/05).
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/94528/2005).
6. Romer T, Peter F, Saenger P, et al: Efficacy and safety of a new ready-to-use recombinant human growth hormone solution. J Endocrinol Invest 2007;30:578-589.
7. Guideline on Risk Management Systems for Medicinal Products for Human Use (EMEA/CHMP/96268/2005).
8. European Public Assessment Report Omnitrope (http://www.emea.europa.eu/ humandocs/Humans/EPAR/omnitrope/omnitrope.htm)