Biogenerics 2007: How far have we come?

Journal of Commercial Biotechnology

Volumn 14, Issue 1, 2008, Pages 56-64

  Tucker, John ^a   Yakatan, Seth ^a   Yakatan, Stan ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

COMPETITION; DRUG PRODUCTS; GENETIC ENGINEERING; HORMONES; INNOVATION; PATENTS AND INVENTIONS;

BIOGENERICS; BIOPHARMACEUTICALS; SECOND-GENERATION INNOVATOR PRODUCTS;

BIOTECHNOLOGY;

ACETYLSALICYLIC ACID; ALPHA INTERFERON; ALPHA2A INTERFERON; ANTINEOPLASTIC AGENT; ATORVASTATIN; BETA INTERFERON; BETA1A INTERFERON; CANCER ANTIBODY; GENERIC DRUG; GRANULOCYTE COLONY STIMULATING FACTOR; HUMAN GROWTH HORMONE; INSULIN; INSULIN DERIVATIVE; MONOCLONAL ANTIBODY; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GLUCAGON; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT HUMAN INSULIN; SALCATONIN; SILDENAFIL; TUMOR NECROSIS FACTOR ANTIBODY;

ANEMIA; ARTICLE; COMPETITION; DIABETES MELLITUS; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG RESEARCH; DRUG SAFETY; DRUG SYNTHESIS; EUROPE; EXPIRATION DATE; GROWTH HORMONE DEFICIENCY; MULTIPLE SCLEROSIS; NEOPLASM; NEUTROPENIA; PATENT; PHARMACEUTICAL CARE; PRACTICE GUIDELINE; RESOURCE ALLOCATION; VIRUS HEPATITIS;

EID: 37749051532     PISSN: 14628732     EISSN: None     Source Type: Journal    
DOI: 10.1057/palgrave.jcb.3050080     Document Type: Article

References (22)

1. Top 20 Biologicals, published on the web by LaMerie Business Intelligence, accessed at http://www.pipelinereview.com/joomla/content/ view/13675/302/, on 27th September, 2007.
2. Hospira press release 20th November, 2006, accessed at http://www.hospira.com/NewsAndMediaCenter/pressrelease.aspx?rid= 20061120.aspx, 27th September, 2007.
3. BioPartners press release, 5th April, 2006, accessed at http://www.biopartners.ch/news/040506.htm, on 27th September, 2007.
4. Belsey, M. J., Harris, L. M., Das, R. R. & Chertkow, J. (2006). Biosimilars: Initial excitement gives way to reality. Nat. Rev. Drug Disc. 5, 535-536.
5. Yakatan, S. & Mintz, C. (2005). Does a biogenerics industry really exist? BioExecutive Int., 1, January, 2-6.
6. Covic, A. & Kuhlmann, M. K. (2007). Biosimilars: Recent developments. Int. Urol. and Nephrol. 39, 261-266.
7. Locatelli, F. & Roger, S. (2006). Comparative testing and pharmacovigilance of biosimilars. Nephrol. Dial. Transplant 21 5), v13-v16.
8. Jelkmann, W. (2005). Recombinant erythropoietins - The role of glycosylation in receptor binding, action, and degradation, European Kidney and Urological Disease 2006, November 2005 22-24, accessed online at http://www.touchgenitourinarydisease.com/download.cfm?step= 2&type=art&type_id=1242, on 27th September, 2007.
9. Royston, J. (2005). Glycosylation of recombinant antibody therapeutics. Biotechnol. Progr. 21, 11-16.
10. Lasne, F. & de Ceaurriz, J. (2000). Recombinant erythropoietin in urine. Nature 405, 635.
11. Johnson, J. A. FDA regulation of follow-on biologics, Congressional Research Service Report for Congress, 18th June, 2007, accessed online at http://opencrs.cdt.org/rpts/RL34045_20070618.pdf, on 27th September 2007.
12. http://www.fda.gov/cder/ob/default.htm.
13. http://thomas.loc.gov/cgi-bin/query/z?c110:h1038, accessed 27th September, 2007.
14. http://thomas.loc.gov/cgi-bin/query/z?c110:H.R.1956, accessed 27th September, 2007.
15. http://thomas.loc.gov/cgi-bin/query/z?c110:S.1695, accessed 27th September, 2007.
16. Woodcock, J., Griffin, J., Behrman, R., Cherney B., Crescenzi, T., Fraser, B., Hixon, D., Joheckis, C., Kozlowski, S., Rosenberg, A., Schrager, L., Shacter, E., Temple, R., Webber, K. & Winkle, W. (2007). The FDA's assessment of follow-on protein products: A historical perspective. Nat. Rev. Drug Disc. 6, 437-442.
17. It is worth noting that calcitonin and glucagon are much smaller proteins than somatropin and that the sponsors of the Avonex application had access to proprietary information and samples that would not normally be available for establishing comparability in a follow-on biological application.
18. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/index.htm.
19. http://www.emea.europa.eu/index/indexh1.htm.
20. European Medicines Agency, Questions and Answers on Recommendation for Refusal of Marketing Application for Alpheon, 28th June, 2006. http://www.emea.europa.eu/pdfs/human/opinion/19089606en.pdf.
21. For an excellent review of the economics of biosimilar development, see Grabowski, H. Cockburn, I. & Long, G. (2006). The market for follow-on biologics: How will it evolve? Health Aff. 25, 1291-1300, and references therein.
22. Pisani, J. & Bonduelle, Y. (2006). Opportunities and Barriers in the Biosimilar Market: Evolution or Revolution for Generics Companies? BioPharm Knowledge Publishing, London.