Biosimilar Drugs

Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications

Volumn , Issue , 2012, Pages 285-335

  Hinderer, Walter ^a  

^a Gedeon Richter Pharma GmbH   (Germany)

Author keywords

Biogenerics; Biopharmaceuticals; Biosimilar guidelines; Biosimilars; Recombinant antibodies; Recombinant therapeutic proteins

Indexed keywords

EID: 84874177377     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9783527632909.ch13     Document Type: Chapter

References (45)

1. German Association of Research-Based Pharmaceutical Companies (vfa-bio) (2009) Medical biotechnology in Germany 2009-Economic data for biopharmaceuticals and therapeutic progress through antibodies (BCG-Report, in German). The Boston Consulting Group (June 2009), pp. 1-48, http://www.vfa.de/vfa-bio-en (accessed 26 March 2010).
2. German Association of Research-Based Pharmaceutical Companies (vfa-bio) (2010) Approved genetechnological pharmaceuticals in Germany (in German) (March 2010). http://www.vfa.de/gentech (accessed 26 March 2010).
3. German Association of Research-Based Pharmaceutical Companies (vfa) (2009) Statistics 2009-The pharmaceutical industry in Germany (vfa-report) (June 2009), pp. 1-61. http://www.vfa.de/vfa-bio-en (accessed 26 March 2010).
4. Lanthier, M., Behrman, R., and Nardinelli, C. (2008) Economic issues with follow-on protein products. Nat. Rev. Drug Discov., 7 (9), 733-737.
5. Brown, P., Preece, M., Brandel, J.P., et al. (2000) Iatrogenic Creutzfeldt-Jakob disease at the millennium. Neurology, 55 (8), 1075-1081.
6. Mannucci, P.M. and Giangrande, P.L.F. (2000) Choice of replacement therapy for hemophilia: recombinant products only? Hematol. J., 1 (2), 72-76.
7. Schernthaner, G. (1993) Immunogenicity and allergenic potential of animal and human insulins. Diabetes Care, 16 (Suppl. 3), 155S-165S.
8. Chance, R.E. and Frank, B.H. (1993) Research, development, production, and safety of biosynthetic human insulin. Diabetes Care, 16 (Suppl. 3), 133S-142S.
9. Schellekens, H. (2002) Bioequivalence and the immunogenicity of biopharmaceuticals. Nat. Rev. Drug Discov., 1 (6), 457-462.
10. The European Agencyfor the Evaluation of Medicinal Products (2003) Guideline on comparability of medicinal products containing biotechnology-derived proteins as active substance: quality issues. CPMP/BWP/3207/00/Rev1 (December 11, 2003).
11. The European Agency for the Evaluation of Medicinal Products (2004) Directive 2004/27/EC of the European Parliament and the Council of 31 March 2004 amending directive 2001/83/EC on the Community code relating to medicinal products for human use. Official J. Eur. Union, L136, 34-57.
12. European Medicines Agency (2010) Scientific guidelines for human medicinal products. Biosimilar guidelines. http://www.ema.europa.eu/htms/human/humanguidelines/multidiscipline.htm (accessed 19 April 2010).
13. Critical comments and opinions on biosimilar regulation, see: Schellekens, H., and Moors, E. (2010) Clinical comparability and European biosimilar regulations. Nature Biotechnol., 28 (1), 28-31.
14. Reviews international biosimilar legislation and products, see: Kresse, G.-B. (2009) Biosimilars-Science, status and strategic perspective. Eur. J. Pharm. Biopharm., 72, 479-486.
15. Rosen, D.L., Bonilla, J.D.W., Beaver, N.A., and Maebius, S.B. (2010) United States: Update-United States enacts approval pathway for biosimilars. Foley & Lardner LLP-Life Science Legal News Alert (March 2010). http://www.foley.com/publications/pub_ detail.aspx?pubid=6965 (accessed 20 April 2010).
16. Sorscher, S. (2009) A longer monopoly for biologics? Considering the implications of data exclusivity as a tool of innovation policy. Harv. J. Law Technol., 23 (1), 285-308.
17. Schwarzenberger, I. (2009) Global development, the way forward-the EGA's perspective. Presentation at the 7th EGA Annual Symposium on Biosimilars (23 April 2009) in London. http://www.egagenerics.com/doc/ega_ biosimilars_Schwarzenberger_090424.pdf (accessed 7 May 2010).
18. Enlarged Board of Appeal (2010) Decision G02/08 (T1319/04, dosage regime): Nicotinic acid compositions for treating hyperlipidemia. European Patent Office (19 February 2010). http://documents. epo.org/projects/babylon/eponet.nsf/0/1c9976e4866080a2c12576cf00417e3e/$ (accessed 16 April 2010)
19. Roche Products Inc. v. Bolar Pharm Co., (1984) U.S. Court of Appeals for the Federal Circuit, Fed. Cir. 733F.2d 858. i. http://cases.justia.com/us-court-of-appeals/F2/733/858/459501/(accessed 30 April 2010).
20. The European Parliament and the Council (2006) Regulation 1901/2006 of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Official J. Eur. Union, L378, 1-19.
21. European Medicines Agency (2010) EPARs for authorised medicinal products for human use. http://www.ema.europa.eu/htms/human/epar/a.htm (accessed 5 May 2010).
22. Rote Liste® (2010) German Pharmaceutical Compendium, Medication Information for Germany. http://www.rote-liste.de/ (accessed 5 May 2010).
23. Wishart, D.S., Knox, C., Guo, A.C., et al. (2008) DrugBank: a knowledgebase for drugs, drug actions and drug targets. Nucleic Acids Res., 36 (1) (database issue): D901-D906.
24. Williams, B.R. and Shen, D.W. (2009) Current considerations for biosimilar therapeutics. Trends Bio/Pharm. Ind., 5 (4), 8-18.
25. Dowlat, H.A. (2009) Fresh insights into the practicalities of developing biosimilar biologics. RAPS Focus (Circular of the Regulatory Affairs Professionals Society) October: 1-6. http://www.parexelcon sulting. com/ne ws/authored-articles (accessed 30 March 2010).
26. Roth, I.R. and Fleischer, N.M. (2009) A follow-on biological drug is not a biogeneric: lessons from Omnitrope and Valtropin. J. Gen. Med., 6 (3), 237-245.
27. Saenger, P. (2009) Current status of biosimilar growth hormone. Int. J. Pediatr. Endocrinol., doi: 10.1155/2009/370329. E-pub 29 September 2009.
28. Williams, B.R. and Strohl, W.R. (2009) Follow-on protein products: what, where, when, how? in Therapeutic Monoclonal Antibodies (ed. Z. An), John Wiley & Sons, Inc., Hoboken, pp. 763-777.
29. Kes, P., Essaian, A., and Gertz, B. (2009) Subcutaneous epoetin theta shows a similar efficacy and safety profile as epoetin beta for a maintenance treatment of renal anaemia in pre-dialysis patients. Nieren-und Hochdruckerkrankungen, 38 (9), 449.
30. Storring, P.L., Tiplady, R.J., Gaines Das, R.E., Stenning, B.E., Lamikanra, A., Rafferty, B., and Lee, J. (1998) Epoetin alfa and beta differ in their erythropoietin isoform composition and biological properties. Brit.J. Hematol., 100, 79-89.
31. Historical and scientific retrospect on the PRCA syndrome, see: Mckoy, J.M., Stonecash, R.E., Cournoyer, D., et al. (2008) Epoetin-associated pure red cell aplasia: past, present, and future. Transfusion, 48 (8), 1754-1762.
32. Del Giglio, A., Enui, A., Ganea-Motan, D., Topuzov, E., and Lubenau, H. (2008) XM02 is superior to placebo and equivalent to Neupogen in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle I in breast cancer patients receiving docetaxel/doxorubicin chemotherapy. BMC Cancer, 8 (332), 1-7. (e-pub November 12, 2008).
33. Gatzemeier, U., Ciuleanu, T., Dediu, M., Ganea-Motan, E., Lubenau, H., and Del Giglio, A. (2009) XM02, the first biosimilar G-CSF, is safe and effective in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in patients with small cell or non-small cell lung cancer receiving platinum-based chemotherapy. J. Thorac. Oncol., 4 (6), 736-740.
34. Engert, A., Griskevicius, L., Zyuzgin, H., and Del Giglio, A. (2009) XM02, the first granulocyte colony-stimulating factor biosimilar, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with non-Hodgkin lymphoma receiving chemotherapy. Leuk. Lymphoma, 50 (3), 374-379.
35. Gascon, P., Fuhr, U., Sörgel, F., et al. (2010) Development of a new G-CSF product based on biosimilarity assessment. Ann. Oncol., 21 (7), 1419-1429.
36. European Medicines Agency (2009) EPARs for authorised medicinal products for human use. Withdrawals of Application-Medicinal Products for Human Use: Biferonex. Assessment Report, 6 August 2009. http://www.ema.europa.eu/humandocs/Humans/EPAR/biferonex/biferonexW.htm (accessed 18 April 2010).
37. A thorough review on PEGylation of biopharmaceuticals, see: Jevsevar, S., Kunstelj, M., and Porekar, V.G. (2010) PEGylation of therapeutic proteins. Biotechnol. J., 5, 113-128.
38. F. Hofmann-La Roche Ltd (2010) Media release. Basel, 3 February 2010. Global web page http://www.roche.com/media/media_releases/med-cor-2010-02-03.htm (accessed 7 May 2010).
39. DeFrees, S., Wang, Z.-G., Xing, R., et al. (2006) GlycoPEGylation of recombinant proteins produced in Escherichia coli. Glycobiology, 16 (9), 833-843.
40. Shibasaki, S. and Ueda, M. (2009) Therapeutic antibodies and other proteins obtained by molecular display technologies. Recent Pat. Biotechnol., 3 (1), 19-27.
41. A comprehensive review with a detailed product data collection, see: Strohl, W.R. (2009) Therapeutic monoclonal antibodies: past, present, and future, in Therapeutic Monoclonal Antibodies (ed. Z. An), John Wiley & Sons, Inc., Hoboken, pp. 3-50.
42. Interesting view of a member of the CHMP, see: Schneider, C.K. and Kalinke, U. (2008) Toward biosimilar monoclonal antibodies. Nat. Biotechnol., 26 (9), 985-990.
43. Mimura, Y., Jefferis, R., Mimura-Kimura, Y., Abrahams, J., and Rudd, P.M. (2009) Glycosylation of therapeutic IgG, in Therapeutic Monoclonal Antibodies (ed. Z. An), John Wiley & Sons, Inc., Hoboken, pp. 67-89.
44. Deep insight into the mAb production aspects and industrial economy, see: Kelley, B. (2009) Industrialization of mAB production technology. The bioprocessing industry at a crossroads. MABs, 1 (5), 443-452.
45. Teva and Lonza announces strategic partnership. Press release of Lonza Group Ltd., January 2009. http://www. lonza.com/group/en/company/news/archive/news_2009/teva_and_lonza_ announce.html (accessed 31 May 2010).