European regulatory guidelines for biosimilars

Nephrology Dialysis Transplantation

Volumn 21, Issue SUPPL. 5, 2006, Pages

  Wiecek, Andrzej ^a   Mikhail, Ashraf ^b  

^a MEDICAL UNIVERSITY OF SILESIA   (Poland)

^b MORRISTON HOSPITAL   (United Kingdom)

Author keywords

Biopharmaceuticals; Biosimilars; EMEA; Regulatory guidelines

Indexed keywords

HUMAN GROWTH HORMONE; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT HUMAN INSULIN; RECOMBINANT PROTEIN;

ANEMIA; CLINICAL TRIAL; DRUG CONTROL; DRUG EFFICACY; DRUG MANUFACTURE; DRUG QUALITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPE; GOVERNMENT REGULATION; GROWTH HORMONE DEFICIENCY; HUMAN; IMMUNOGENICITY; LEGAL ASPECT; PHARMACODYNAMICS; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PURE RED CELL ANEMIA; REVIEW; RISK BENEFIT ANALYSIS; SINGLE DRUG DOSE;

BIOLOGICAL PRODUCTS; DRUG APPROVAL; EUROPE; GUIDELINES; GUIDELINES AS TOPIC; HUMANS; LEGISLATION, DRUG; PHARMACEUTICAL PREPARATIONS; PRODUCT SURVEILLANCE, POSTMARKETING; THERAPEUTIC EQUIVALENCY;

EID: 33748707376     PISSN: 09310509     EISSN: 14602385     Source Type: Journal    
DOI: 10.1093/ndt/gfl477     Document Type: Review

References (16)

1. The European Parliament and the Council of the European Union. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official Journal of the European Union 2001; 67-128
2. The Commission of the European Communities. 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 of the European Union 2003; 46-94
3. The European Parliament and the Council of the European Union. Directives 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 of the European Union 2004; 34-57
4. Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products. CHMP/437/04 2005
5. Committee for Proprietary Medicinal Products. Guideline on comparability of medicinal products containing biotechnology-derived proteins as active substance. Non-clinical and clinical issues. EMEA/CPMP/3097/02/ Final 2003
6. Committee for Proprietary Medicinal Products. Guideline on comparability of medicinal products containing biotechnology-derived proteins as active substance: Quality issues. EMEA/ CPMP/BWP/3207/00/Rev 1 2003
7. Committee for Medicinal Products for Human Use. Guidelines on similar biological medicinal products containing biotechnology-derived proteins as active substance: Quality issues. European Medicines Agency. EMEA/ CHMP/BWP/ 49348/2005, 23 November 2005
8. Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues. EMEA/CHMP/42832/ 2005
9. Committee for Medicinal Products for Human Use. 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 recombinant human insulin. EMEA/ CHMP/32775/ 2005
10. Committee for Medicinal Products for Human Use. Concept Paper, similar biological medicinal products containing recombinant human insulin. Annex to the guideline for the development of similar biological medicinal products containing biotechnology derived proteins as active substance: (Non) clinical issues. CHMP/Comparability Working Party/ 146710/ 2004
11. Committee for Medicinal Products for Human Use. 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
12. Committee for Medicinal Products for Human Use. Concept Paper, similar biological medicinal products containing recombinant human growth hormone. Annex to the guideline for the development of similar biological medicinal products containing biotechnology derived proteins as active substance: (Non) clinical issues. CHMP/Comparability Working Party/146489/2004 corr. 2004
13. Committee for Medicinal Products for Human Use. Annex guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues. Guidance on biosimilar medicinal products containing recombinant granulocyte-colony stimulating factor. EMEA/CHMP/31329/2005
14. Committee for Medicinal Products for Human Use. Concept Paper, similar biological medicinal products containing recombinant human granulocyte -colony stimulating factor. Annex to the guideline for the development of similar biological medicinal products containing biotechnology derived proteins as active substance: (Non) clinical issues. CHMP/ Comparability Working Party/146701/2004
15. Committee for Medicinal Products for Human Use. Annex guideline on similar biological medicinal products containing biotechnology-Derived proteins as active substanceG Non-clinical and clinical issues: guidance on biosimilar medicinal products containing recombinant erythropoietins. European Medicines Agency. EMEA/CHMP/94526/2005
16. Committee for Medicinal Products for Human Use. Concept Paper, similar biological medicinal products containing recombinant human erythropoietin. Annex to the guideline for the development of similar biological medicinal products containing biotechnology derived proteins as active substance: (Non) clinical issues. CHMP/Comparability Working Party/146664/2004