Basic facts about biosimilars

Kidney and Blood Pressure Research

Volumn 30, Issue 5, 2007, Pages 267-272

  Nowicki, Michał ^a,b  

^a MEDICAL UNIVERSITY OF LODZ   (Poland)

^b N Barlicki University Hospital No 1 of Medical University of Lodz   (Poland)

Author keywords

Biologics, follow on; Biosimilars; Biotechnological medicines; Epoetin; Immunogenicity

Indexed keywords

RECOMBINANT ERYTHROPOIETIN;

ANEMIA; BIOTECHNOLOGY; CHRONIC KIDNEY DISEASE; DRUG LABELING; DRUG MANUFACTURE; DRUG SURVEILLANCE PROGRAM; HUMAN; IMMUNOGENICITY; PRESCRIPTION; PRIORITY JOURNAL; RENAL ANEMIA; REVIEW;

ANIMALS; BIOLOGICAL PRODUCTS; BIOTECHNOLOGY; DRUGS, GENERIC; HUMANS; THERAPEUTIC EQUIVALENCY;

EID: 34548147147     PISSN: 14204096     EISSN: None     Source Type: Journal    
DOI: 10.1159/000105133     Document Type: Review

References (23)

1. Schellekens H: Biopharmaceuticals and biosimilars, unraveling the complexity. EJHP Pract 2006;12:13.
2. Roger SD: Biosimilars: how similar or dissimilar they are. Nephrology 2006;11:341-346.
3. Karpusas M, Whitty A, Runkel L, Hochman P: The structure of human interferon-beta: implications for activity. Cell Mol Life Sci 1998;54:1203-1216.
4. http://www.phrma.org/files/Biotech%202006.pdf
5. Storring PL, Triplady RJ, Gaines Das RE, Rafferty B, Mistry YG: Lectin-binding assays for the isoforms of human erythropoietin: comparison of urinary and four recombinant erythropoietins. J Endocrinol 1996; 150:401-412.
6. Schmidt CA, Ramos AS, da Silva JEP, Fronza M, Dalmora SL: Activity evaluation and characterization of recombinant human erythropoietin in pharmaceutical products. Arg Bras Endocrinol 2003;47:183-189.
7. Molowa DT, Mazanet R: The state of biopharmaceutical manufacturing. Biotechnol Ann Rev 2003;8:285-302.
8. Schellekens H: Follow-on biologics: challenges of the 'next generation'. Nephrol Dial Transplant 2005;20(suppl 4):iv31-iv36.
9. Nau JY: Omnitrope, first 'biosimilar' drug of the European Union. Rev Med Suisse 2006; 2:1206.
10. Burger J: The first approved biotech-generic. Versicherungsmedizin 2006;58:190-191.
11. http://www.redorbit.com/news/health/557861/ european_panel_snubs_biopartners_alpheon/index.html
12. http://www.emea.eu.int/pdfs/human/biosimilar/4283205en.pdf
13. http://www.europabio.org/articles/PR_Biosimilars_070221_FINAL.pdf
14. Combe C, Tredree RL, Schellekens H: Biosimilar epoetins: an analysis based on recently implemented European Medicines Evaluation Agency guidelines on comparability of biopharmaceuticals proteins. Pharmacotherapy 2005;25:954-962.
15. http://www.emea.eu.int/pdfs/human/biosimilar/9452605en.pdf
16. Wiȩcek A, Mikhail A: European regulatory guidelines for biosimilars. Nephrol Dial Transplant 2006;21(suppl 5):v17-v20.
17. http://www.ebe-biopharma.org/forcedownload.php?file=/media/biosimilars/ biosimilars_subsitutionpos.pdf
18. Thorpe R, Wadhwa M: Protein therapeutics and their immunity. EJHP Pract 2006;12: 17-19.
19. Casadevall N, Rossert J: Importance of biologic follow-ons: experience with EPO. Best Pract Res Clin Haematol 2005;18:381-387.
20. Lim LC: Acquired red cell aplasia in association with the use of recombinant erythropoietin in chronic renal failure. Hematology 2005;10:255-259.
21. Locatelli F, Roger S: Comparative testing and pharmacovigilance of biosimilars. Nephrol Dial Transplant 2006;21(suppl 5):v13-v16.
22. http://www.ebe-biopharma.org/docs/pdf/ Biosims_EBEEFPIAPosition_Naming_7July2006.pdf
23. http://www.ebe-biopharma.org/forcedownload.php?file=/media/biosimilars/ biosimilars_subsitutionpos.pdf