Experiences with biosimilar drugs in therapy
Authors:
Jaroslav Škvor
Authors‘ workplace:
Dětská klinika UJEP a Masarykovy nemocnice, Krajská zdravotní a. s., Ústí nad Labem, přednosta prim. MUDr. Jaroslav Škvor, CSc.
Published in:
Vnitř Lék 2015; 61(3): 207-208
Category:
Review
Overview
Biosimilar drugs or drugs which are similar to reference biological drugs represent a new treatment option within the biological treatment. They are already the standard biotherapeutics option in some fields of medicine, in others as in diabetology, remain to be evaluated. The article presents the definition of biosimilar drugs and summarizes the therapeutic benefits and attitudes of agencies for drug control in the United States and Europe.
Key words:
biosimilar drugs – biotherapy – diabetology
Sources
1. Světová zdravotnická organizace. Expertní komise pro biologickou standardizaci. Pokyny pro hodnocení podobných bioterapeutických přípravků (Guidelines on Evaluation of Similar Biotherapeutic Products, SBP). Světová zdravotnická organizace. [Online] 23. října 2009. Dostupné z WWW: <http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf>.
2. Owens DR, Landgraf W, Schmidt A et al. The emergence of biosimilar insulin preparations--a cause for concern? Diabetes Technol Ther 2012; 14(11): 989–996.
3. Schellekens H, Moors E. Clinical comparability and European biosimilar regulations. Nat Biotechnol 2010; 28(1): 28–31.
4. Heinemann L. Biosimilar Insulins. Expert Opin Biol Ther 2012; 12(8): 1009–1016.
5. Heinemann L, Hompesch M. Biosimilar Insulins: Basic Considerations. J Diabetes Sci Technol 2014; 8(1): 6–13.
6. DeVries JH, Gough SCL, Kiljanski J et al. Biosimilar insulins: a European perspective. Diabetes Obes Metab 2014. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.12410>.
7. Rotenstein LS, Ran N, Shiverset JP et al. Opportunities and Challenges for Biosimilars: What‘s on the Horizon in the Global Insulin Market? Clin Diabetes 2012; 30(4): 138–150.
Labels
Diabetology Endocrinology Internal medicineArticle was published in
Internal Medicine
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