Biosimilar insulin as an alternative for the original products
Abstract
The medical knowledge makes a great progress in methods of treating diseases that makes our life much longer. Diabetes is a typical disease of civilization affecting more and more people all over the world. The cost of insulin therapy constitutes a great part of all expenditures associated with the treatment of patients with diabetes mellitus type 1 and type 2. Nowadays, when the patents covering biological insulins expire, new possibilities of using biosimilar insulins in treating diabetic patients appear. What is more, this group of products seems to be very promising. The authors describe, how the biopharmaceuticals and biosimilar drugs started to be used in the treatment. They present the similarities and differences between the biosimilars, original drugs and also generic products, with taking special interest in immunogenicity and the safety profile. The authors also point out the potential advantages and the risk of possible side effects of using biosimilar insulins in patients suffering from diabetes.
Keywords: biopharmaceuticalsbiosimilar drugsbiosimilar insulins
References
- Commission Directive 2003/63/EC of June 2003 amending Directive 2001/83/EC of the European Parliament and Council on the Community code relating to medicinal products for human use.
- Zieliński W. Biotechnologia. Monografie. 2009; 5: 57–74.
- Bogiel M, Marzec A. Leki biopodobne — pełnowartościowe, nowoczesne preparaty biotechnologiczne. Terapia i Leki. 2008; 35/57(2): 40–50.
- Lanao JM, Briones E, Colino CI. Recent advances in delivery systems for anti-HIV1 therapy. J Drug Target. 2007; 15(1): 21–36.
- Sekhon B, Saluja V. Biosimilars: an overview. Biosimilars. 2011; 1: 1–11.
- Roger SD. Biosimilars: current status and future directions. Expert Opin Biol Ther. 2010; 10(7): 1011–1018.
- Kresse GB. Biosimilars--science, status, and strategic perspective. Eur J Pharm Biopharm. 2009; 72(3): 479–486.
- Nowicki M, Zimmer-Nowicka J. Biofarmaceutyki oryginalne i leki biopodobne — co należy o nich wiedzieć, aby zapewnić bezpieczeństwo leczenia? Onkol Prakt Klin. 2007; 3: 120–127.
- Schmidt C, Ramos A, Silva J, et al. Avaliação da atividade e caracterização de eritropoietina humana recombinante em produtos farmacêuticos. Arquivos Brasileiros de Endocrinologia & Metabologia. 2003; 47(2): 183–189.
- Schellekens H. Follow-on biologics: challenges of the "next generation". Nephrol Dial Transplant. 2005; 20 Suppl 4: iv31–iv36.
- Schellenkens H. Biopharmaceuticals and biosimilars, unraveling the complexity. EJHP Practice. 2006; 12: 13.
- Crommelin D, Bermejo T, Bissig M, et al. Biosimilars, generic versions of the first generation of therapeutic proteins: do they exist? Contrib Nephrol. 2005; 149: 287–294.
- Crommelin DJA, Storm G, Verrijk R, et al. Shifting paradigms: biopharmaceuticals versus low molecular weight drugs. Int J Pharm. 2003; 266(1-2): 3–16.
- EMA 2013. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/002778/human_med_001677. jsp&mid=WC0b01ac058001d124.
- Diabetes drug and device industry 1Q12 finacial model. . Close Concerns, Inc, San Francisco 2012.
- International Diabetes Federation: Healthcare expenditures. http://www.idf.org/diabetesatlas/5e/healthcare-expenditures (17.06.2012).
- Biocon. Biocon launches BASALOG — long lasting basal insulin for type 1&type2 diabetics. http://www.biocon.com/biocon_inv_ press_relaeses_29may2009.asp (04.2015).
- uropean Commission grants Lilly and Boehringer Ingleheim’s insulin glargine product marketing authorization in Europe. Press release of Eli Lilly and Boehringer Ingelheim, http://www.boehringeringelheim.com/news/news_releases/ /press_relaeses/2014/10_september_2014_insulin_glargine.html (10.09.2014).
- García-Nares H, Leyva-Carmona MI, Pérez-Xochipa N, et al. Hypersensitivity reaction to a biosimilar insulin glargine. J Diabetes. 2015; 7(2): 155–157.
- Rader RA. An analysis of the US biosimilars development pipeline and likely market evolution. Bio Process Int. 2013; 11: 16–23.