Skip to main content

Advertisement

SpringerLink
Log in

Biosimilar Growth Hormone

  • Symposium on Growth Hormone
  • Published:
The Indian Journal of Pediatrics Aims and scope Submit manuscript

Abstract

As the first wave of biopharmaceuticals is expiring, biosimilars or follow-on -protein products (FOPP’s) have emerged. Biosimilar drugs are cheaper than the originator/comparator drug. The regulatory foundation for these products is more advanced and better codified in Europe than in the US. Biosimilar soamtropin has been approved in both the US and Europe. The scientific viability of biosimilar drugs and especially growth hormone has been proven by several rigorously conducted clinical trials. Efficacy and safety data (growth rates, IGF-1 generation) for up to 7 y for pediatric indications measure up favorably to previously approved growth hormones which served as reference comparators. The Obama Administration appears to be committed to establish innovative pathways for the approval of biologics and biosimilars in the US. The cost savings in health care expenditures will be substantial as the global sales of biologics have reached $ 93 billion in 2009.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Dudzinski DM, Kesselheim AS. Scientific and legal viability of follow-on protein drugs. NEJM. 2008;358:843–9.

    Article  PubMed  CAS  Google Scholar 

  2. Kelly CJ, Mir FA. Economics of biological therapies. BMJ. 2009;339:b3276.

    Article  PubMed  Google Scholar 

  3. Goldman DP, Joyce GF, Lawless G, Crown WH, Willey V. Benefit design and specialty drug use. Health Aff (Millwood). 2006;25:1319–31.

    Article  Google Scholar 

  4. Golenski JD. Specialist discretion for managing specialty pharmaceuticals: the ethics argument for discretion. Am J Manag Care. 2004;10:S240–1. discussion 245–51.

    PubMed  Google Scholar 

  5. Mullins CD, De Vries AR, Hsu VD, Meng F, Palumbo FB. Variability and growth in spending for outpatient specialty pharmaceuticals. Health Aff (Millwood). 2005;24:1117–27.

    Article  Google Scholar 

  6. Glasbrenner K. Technology spurt resolves growth hormone problem, ends shortage. (Medical News). JAMA. 1986;255:581–4. 587.

    Article  PubMed  CAS  Google Scholar 

  7. US. Food and Drug Administration The Orphan Drug Act. www.fda.gov/forindustry/developingproductsforrarediseasesconditions/overview/ucm1194779(accessed Feb 2011).

  8. Maeder T. The orphan drug backlash. Sci Am. 2003;288:80–7.

    Article  PubMed  Google Scholar 

  9. Brewer GJ. Drug development for orphan diseases in the context of personalized medicine. Trans Res. 2009;154:314–22.

    Article  CAS  Google Scholar 

  10. Anand G. Lucrative niches: how drugs for rare diseases become lifeline for companies. Wall St J. 2005;15:A1–A18.

    Google Scholar 

  11. Editorial. Regulating a moving frontier. Regulatory Rapporteur. 2009;6:8–9.

    Google Scholar 

  12. European Generic Medicines Association (EGA).Competition and affordability in biopharmaceuticals 2009. http://www/egagenerics.com/ega-biosimilars.htm (accessed Feb 2, 2011)

  13. Pavlovic M, Girardin E, Kapetanovic I, Ho K, Trouvin JH. Similar biological medicinal products containing recombinant human growth hormone. European regulation. Horm Res. 2007;69:14–21.

    Article  PubMed  Google Scholar 

  14. Complant at 112–122, Sandoz Inc v.Leavitt (D.D.C. 2006), 05-cv-1810 c and Sandoz v Leavitt ,427 F. Supp 2d 29,33 ( D.D.C. 2006 b) , on file with author.

  15. Kozlowski S, Woodcock J, Behrman Sherman R, Midthun K. Developing the nation’s biosimilar program. NEJM. 2011;362:85.

    Google Scholar 

  16. Kessler M, Goldsmith D, Schellekens H. Immunogenicity of biopharmaceuticals. Nephrol Dial Transplant. 2006;21:v0–v12.

    Article  Google Scholar 

  17. Louet S. Lessons from Eprex for biogeneric firms. Nat Biotechnol. 2003;21:956–7.

    Article  PubMed  CAS  Google Scholar 

  18. Schneider CK, Kalinke U. Toward biosimilar monoclonal antibodies. Nat Biotechnol. 2008;26:985–90.

    Article  PubMed  CAS  Google Scholar 

  19. McCamish M, Woolett G. Worldwide experience with biosimilar development. MAbs. 2011;3:209–12.

    Article  PubMed  Google Scholar 

  20. Omnitrope, European Public Assessment Report April 2006, http://www.emea.europaeu/humandocs/Humans/EPAR/omnitrope/omnitrope.htm (accessed Feb 2, 2011).

  21. Valtropin, European Public Assessment Report, April 2006, http://www.emea.europa.eu/humandocs/Humans/EPAR/valtropin/valtropin.htm (accessed Feb 3 2011)

  22. Omnitrope (somatropin) 2006 questions and answers, US Food and Drug Administration, Center for Drug Evaluation and Research, http://www.fda.gov/cder/whatsnew/htm (accessed Feb 3, 2011)

  23. Annex Guideline on Similar Biological Medicinal Products Containing Biotechnology Derived Products as Active Substance: Non-Clinical and Clinical Issues Guidance on Similar Medicinal Products Containing Somatropin, EMES/CHMP/94528/05, CHMP, adopted February 2006

  24. 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;30:578–89.

    PubMed  CAS  Google Scholar 

  25. Romer T, Saenger P, Peter F, et al. Seven years of safety and efficacy of the recombinant human growth hormone Omnitrope in the treatment of human growth hormone deficient children: results of a Phase III study. Horm Res. 2009;72:359–69.

    Article  PubMed  CAS  Google Scholar 

  26. Peterkova V, Arslanoglu E, Bolshova-Zubkovskaya, et al. A randomized double-blind study to assess efficacy and safety of valtropin, a biosimilar growth hormone, in children with growth hormone deficiency. Horm Res. 2007;68:288–93.

    Article  PubMed  CAS  Google Scholar 

  27. Walczak M, Zdavkovic D, Bolshova-Zubkovskaya, et al. A 3 year assessment of the efficacy and safety profile of Valtropin. a recombinant human growth hormone, in children with growth hormone deficiency. Horm Res. 2008;70:97.

    Google Scholar 

  28. Peterkova V, Savoy C, Bezlepkina V, et al. Efficacy and safety of Valtropin in the treatment of short stature in girls with Turner’s syndrome. J Pediatr Endocrinol Metabol. 2004;17:1429–34.

    Article  CAS  Google Scholar 

  29. Declerck PJ, Darendeliler, Goth M, et al. Biosimilars controversies as illustrated by GH. Curr Med Res Opin. 2010;26:1219–29.

    Article  PubMed  CAS  Google Scholar 

  30. Ranke MB. New preparations comprising recombinant human growth hormone: deliberations on the issue of biosimilars. Horm Res. 2007;69:22–8.

    Article  PubMed  Google Scholar 

  31. Hoppe W, Berghout A. Biosimilar somatropin: myths and facts. Horm Res. 2007;69:29–30.

    Article  PubMed  Google Scholar 

  32. Newsletter 2009–130 German Medical Association. Newletter @ akdae.de January 2009.

  33. Sperling MA, Saenger PH, Hintz R, Wilson T, Rose SR. Growth hormone treatment and neoplasia- coincidence or consequence. J Clin Endocrinol Metab. 2002;87:5351–2.

    Article  PubMed  CAS  Google Scholar 

  34. Cuttler L, Silvers JB. Growth hormone and health policy. J Clin Endocrinol Metab. 2010;95:3149–53.

    Article  PubMed  CAS  Google Scholar 

  35. FDA Public Hearing on Approval Pathway for Biosimilars and Interchangeable Biological Products. 11/3/2010 Transcript Document ID: FDA −2010—N 0477-012.www.regulations.govsearch/Regs/home.Html#documentDetail?R=0900006480bafe46.

  36. Federal Register Notice Food and Drug Administration [Docket No FDA-2010 0 N 0477] Approval Pathway for Biosimilar and Interchangeable Biological Products. Public Hearing; Request for Comments http://edocket.access.gpo.gov/2010/pdf2010-24853.pdf.

  37. Biologic Price Competition and Innovations Act (BPCIA) provisions of the Patient Protection and Affordable Care Act (PPACA) http://frebgate.access,gpo.gov/cgi-bin/getdoc.cgi?dbname=111cong.bills&docid=f:3590enr.txt.pdf.

  38. Bell J, Parker KL, Swinford RD, Hoffman AR, Maneatis T, Lippe B. Long- term safety of recombinant human growth hormone in children. J Clin Endocrinol Metab. 2010;95:167–77.

    Article  PubMed  CAS  Google Scholar 

  39. Frank RG. Regulation of follow-on biologics. NEJM. 2007;359:841–3.

    Article  Google Scholar 

  40. EMA Press release 2010 http://www.emaeuropaeu/docs/enGB/documentlibrary/Pressrelease/2010/12/WC500099699.pdf

  41. SAGhE http://saghe.aphp.fr/site/spip.php/

Download references

Conflict of Interest

PS has been a consultatnt to Biopartners, he has received lecture fees from Genentech and TEVA Pharmaceuticals.

Author information

Authors and Affiliations

  1. Department of Pediatrics, Division of Pediatric Endocrinology, Albert Einstein College of Medicine, Bronx, NY, USA

    Paul Saenger

  2. 150 Lockwood Ave Suite 34, New Rochelle, NY, 10804, USA

    Paul Saenger

Authors
  1. Paul Saenger
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Paul Saenger.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Saenger, P. Biosimilar Growth Hormone. Indian J Pediatr 79, 92–98 (2012). https://doi.org/10.1007/s12098-011-0610-y

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12098-011-0610-y

Keywords

Search

Navigation