Vol 5, No 4 (2009)
Review paper
Published online: 2009-07-30

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Some problems associated with substitution of original chemical and biotechnological medicines by their equivalents

Włodzimierz Bialik
Onkol. Prak. Klin 2009;5(4):148-156.

Abstract

Substitution of traditional chemical medicines by their generics is widely accepted, however, in some cases deep consideration should be involved. Original biotechnological medicines - due to their extremely complicated structure and inability to copy manufacturing procedures by other producers that can lead to differences in product identity and quality - should not be automatically replaced by biosimilars. Scientific, technological and legal issues have been discussed to legitimize such statements.

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References

  1. Kayser O, Muller RH. Biotechnologia farmaceutyczna. PZWL, Warszawa 2003: 76–87.
  2. Nightingale CH. Quality evaluation of generic clarithromycins from 13 countries, Clin. Drug Invest. 2000: 582–585.
  3. Augustynowicz SZ. ceną nikt nie wygra. Rynek Zdrowia. 2008; 11: 26–28.
  4. Ciupis M. Mały Indeks Leków Medycyny Praktycznej. Wydawnictwo Medycyna Praktyczna, Kraków 2008.
  5. Kaliszan R, Janicki S. Janicki S. Biorównoważność leków Farm Pol. 2001; 10: 456–462.
  6. Nowicki M, Zimmer-Nowicka J. Biofarmaceutyki oryginalne i leki biopodobne — co należy o nich wiedzieć, by zapewnić bezpieczeństwo leczenia. Onkologia w Praktyce Klinicznej. 2007; 3: 120–127.
  7. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncology. 2007: 1–9.
  8. Schellekens H. Biopharmaceuticals and biosimilars, unraveling the complexity. EJHP Practice. 2006; 12: 13.
  9. Roger SD. Biosimilars: how similar or dissimilar are they? Nephrology (Carlton). 2006; 11(4): 341–346.
  10. Nelson DI, Cox MM. Principles of biochemistry. W.H. Freeman and Co. W.H. Freeman and Co., New York 2008: 113–182.
  11. Schellekens H. When biotech proteins go off-patent. Trends Biotechnol. 2004; 22(8): 406–410.
  12. Gaps in the quality of and potential safety of biosimilar epoetins in the developing world: and international safety. 2008.
  13. Schellekens H. Follow-on biologics: challenges of the 'next generation'. Nephrology Dialysis Transplantation. 2005; 20(suppl_4): iv31–iv36.
  14. Casadevall N, Rossert J. Importance of biologic follow-ons: experience with EPO. Best Pract Res Clin Haematol. 2005; 18(3): 381–387.
  15. http://www.emea.europa.eu/pdfs/human/pcwp/ /7456206en.pdf.
  16. Nowicki M. Czy automatyczna substytucja biofarmaceutyków może być bezpieczna? Służba Zdrowia. 2008; 30: 26–28.
  17. http://www.emea.europa.eu/pdfs/human/biosimilar/3132905en.pdf.