Research Article
Analytical and Sales Data Comparison of Reference Product of Insulin Aspart and its Biosimilar in Turkey
Abstract
In recent years, biosimilar products have become one of the most
popular areas of pharmaceutical industry and pharmaceutical
biotechnology.
As their patents have expired or are about to expire, biotechnology
products, whose manufacture involves more complex processes,
are becoming a focus of interest. Compared to generic products,
complex processes are not limited to manufacture. Preclinical
and clinical development as well as market access process for
biosimilar biological products is also challenging and costly.
Despite these challenges, many companies continue to develop
biosimilar products.
Despite the fact that there are long-term robust data related
to generics, the debate of many topics for biosimilar has just
begun. These topics include the economic contribution of
biosimilar, public cost effects, patient access, clinical trials and
trials comparative with the reference product.
Within the scope of this study, global and Turkey sales data
of biological products containing insulin which was initially
approved in 1982 and was produced by recombinant DNA
technology were reviewed. The study also covered the analytical
comparison of the reference insulin aspart with insulin aspart
biosimilar products and discussed the possible topics that could
be used in development and registration processes.
References
- 1. Blackstone E, Joseph F. The economics of biosimilars. Am Health Drug Benefits 2013; 6: 469-78. 2. Rotenstein LS, Ran N, Shivers J, Yarchoan M, Close K. Opportunities and challenges for biosimilars: What’s on the horizon in the global ınsulin market? Clin Diabetes 2012; 30: 138-50. 3. Greer MF. Biosimilar development: From science to market. Life Sci, SGS Tech Bull 2011; 47: 1-6. 4. Grabowski H, Long G, Mortimer R. Implementation of the biosimilar pathway. Seton Hall Law Rev 2011; 41: 511-57. 5. Heinemann L, Hompesch M. Biosimilar insulins: How similar is similar? J Diabetes Sci Technol 2011; 5: 741-54. 6. Faye L, Gomord V. Recombinant Proteins from Plants. Humana Press.2009. 7. EMA, Human Medicines. http://www.ema.europa.eu/ema/ index.jsp?curl=pages/medicines/human/medicines/002835/ human_med_001790.jsp&mid=WC0b01ac058001d124 (accessed July 3, 2015). 8. GaBI Online, Biosimilars. http://gabionline.net/Biosimilars/ General/Top-8-blockbuster-biologicals-2013 (accessed July 3, 2015). 9. Kayaalp O. Tıbbi Farmakoloji, 11th ed. Hacettepe-Taş. 2005. 10. Walsh G. Pharmaceutical Biotechnology, Concepts and Applications. John Wiley & Sons Ltd. 2007. 11. Çakır B. İnsülin analoglarının diyabetes mellitüs tedavisindeki rolü ve faydaları. Ankara Med J 2012; 2: 22-31. 12. IMS verisi, Email A Ateş, IMS TURKEY 11.02.2015 elektronik posta görüşmesi 13. Nacak M, Sezer Z, Erenmemişoğlu A. Biyobenzer ilaçlar. J Clin Anal Med 2012; 3: 251-6. 14. Simon F. Market access for biopharmaceuticals: New challenges. Health Aff 2006; 25: 1363-70. 15. Edelman S, Polonsky W, Parkin C. Biosimilar insulins are coming: what they are, what you need to know. Curr Med Res Opin 2014; 30: 2217–22. 16. Carter A. Multiple source of biosimilar insulin, what’s a provider to do? J Diabetes Sci Technol 2014; 8: 20–2. 17. Minocha M, Gobburu J. Drug development and potential regulatory paths for ınsulin biosimilars. J Diabetes Sci Technol 2014; 8: 14–9. 18. Bonneil E, Waldron KC. On-line system for peptide mapping by capillary electrophoresis at sub-micromolar concentrations. Talanta 2000; 53: 687–99. 19. Ortner K, Buchberger W, Himmelsbach M. Capillary electrokinetic chromatography of insulin and related synthetic analogues. J. Chromatogr A 2009; 1216: 2953–7. 20. Jars MU, Hvass A, Waaben D. Insulin aspart (AspB28 Human Insulin) derivatives formed in pharmaceutical solutions. Pharm Res 2002; 19: 621-8. 21. Favero-Retto MP, Palmieri LC, Souza TACB, Almeida FCL, Lima LMTR. Structural meta-analysis of regular human insulin in pharmaceutical formulations. Eur J Pharm Biopharm 2013; 85: 1112–21. 22. Kalman-Szekeres Z, Olajos M, Ganzler K. Analytical aspects of biosimilarity issues of proetin drugs. J Pharm Biomed Anal 2012; 69: 185-95. 23. Harazona A, Hashii N, Kuribayashi R, Nakazawa S, Kawasaki N. Mass spectrometric glycoform profiling of the innovator and biosimilar erythropoietin and darbepoetin by LC/ESI-MS. J Pharm Biomed Anal 2013; 83: 65-74. 24. Holzgrabe U, Nap C, Almeling S. Use of collision induced dissociation mass spectrometry as a rapid technique for the identification of pharmacologically active peptides in pharmacopoeial testing. J Pharm Biomed Anal 2011; 55: 957– 63.
Türkiye’de İnsüline Ait Satış Verileri ve Referans İnsülin Aspart ile Biyobenzerinin Analitik Karşılaştırılması
Abstract
Son yıllarda ilaç sanayinin ve ilaç biyoteknolojisinin en popüler
konularından biri biyobenzerlerdir.
Üretimleri daha karmaşık süreçler içeren biyoteknolojik ürünler,
patentlerinin de bitmeye yaklaşması veya bitmesi ile ilgi odağı
olmaktadır. Jenerik ürünler ile karşılaştırıldığında karmaşık
süreçler sadece üretim ile sınırlı değildir. Geliştirme, klinik
süreçleri ve pazara erişim süreçleri de zorlu ve maliyetlidir.
Bu zorluklara rağmen biyobenzer geliştiren ve geliştirme
çalışmaları devam eden birçok şirket bulunmaktadır.
Jenerikler ile ilişkili olarak geçtiğimiz uzun yıllara ait net veriler
olmasına rağmen biyobenzerler için birçok başlık jeneriklere
kıyasla yeni tartışılmaya başlanmıştır. Bu başlıklar arasında
biyobenzerlerin ekonomik katkısı, kamu maliyetine etkileri,
hasta erişimi, klinik çalışmalar ve referans ürün ile karşılaştırma
çalışmalarını sayabiliriz.
Bu araştırma kapsamında 1982 yılında ilk onay alıp,
rekombinant DNA teknolojisi ile üretilmiş biyolojik ürün olan
insülin içeren ürünlerin küresel ve Türkiye’deki satışları ele
alınmıştır. Araştırmada ayrıca referans insülin aspart ürünü ile
insülin aspart biyobenzerinin analitik olarak karşılaştırılması
ele alınmıştır, geliştirme ve ruhsat süreçlerinde kullanılabilecek
olası başlıklar irdelenmiştir.
References
- 1. Blackstone E, Joseph F. The economics of biosimilars. Am Health Drug Benefits 2013; 6: 469-78. 2. Rotenstein LS, Ran N, Shivers J, Yarchoan M, Close K. Opportunities and challenges for biosimilars: What’s on the horizon in the global ınsulin market? Clin Diabetes 2012; 30: 138-50. 3. Greer MF. Biosimilar development: From science to market. Life Sci, SGS Tech Bull 2011; 47: 1-6. 4. Grabowski H, Long G, Mortimer R. Implementation of the biosimilar pathway. Seton Hall Law Rev 2011; 41: 511-57. 5. Heinemann L, Hompesch M. Biosimilar insulins: How similar is similar? J Diabetes Sci Technol 2011; 5: 741-54. 6. Faye L, Gomord V. Recombinant Proteins from Plants. Humana Press.2009. 7. EMA, Human Medicines. http://www.ema.europa.eu/ema/ index.jsp?curl=pages/medicines/human/medicines/002835/ human_med_001790.jsp&mid=WC0b01ac058001d124 (accessed July 3, 2015). 8. GaBI Online, Biosimilars. http://gabionline.net/Biosimilars/ General/Top-8-blockbuster-biologicals-2013 (accessed July 3, 2015). 9. Kayaalp O. Tıbbi Farmakoloji, 11th ed. Hacettepe-Taş. 2005. 10. Walsh G. Pharmaceutical Biotechnology, Concepts and Applications. John Wiley & Sons Ltd. 2007. 11. Çakır B. İnsülin analoglarının diyabetes mellitüs tedavisindeki rolü ve faydaları. Ankara Med J 2012; 2: 22-31. 12. IMS verisi, Email A Ateş, IMS TURKEY 11.02.2015 elektronik posta görüşmesi 13. Nacak M, Sezer Z, Erenmemişoğlu A. Biyobenzer ilaçlar. J Clin Anal Med 2012; 3: 251-6. 14. Simon F. Market access for biopharmaceuticals: New challenges. Health Aff 2006; 25: 1363-70. 15. Edelman S, Polonsky W, Parkin C. Biosimilar insulins are coming: what they are, what you need to know. Curr Med Res Opin 2014; 30: 2217–22. 16. Carter A. Multiple source of biosimilar insulin, what’s a provider to do? J Diabetes Sci Technol 2014; 8: 20–2. 17. Minocha M, Gobburu J. Drug development and potential regulatory paths for ınsulin biosimilars. J Diabetes Sci Technol 2014; 8: 14–9. 18. Bonneil E, Waldron KC. On-line system for peptide mapping by capillary electrophoresis at sub-micromolar concentrations. Talanta 2000; 53: 687–99. 19. Ortner K, Buchberger W, Himmelsbach M. Capillary electrokinetic chromatography of insulin and related synthetic analogues. J. Chromatogr A 2009; 1216: 2953–7. 20. Jars MU, Hvass A, Waaben D. Insulin aspart (AspB28 Human Insulin) derivatives formed in pharmaceutical solutions. Pharm Res 2002; 19: 621-8. 21. Favero-Retto MP, Palmieri LC, Souza TACB, Almeida FCL, Lima LMTR. Structural meta-analysis of regular human insulin in pharmaceutical formulations. Eur J Pharm Biopharm 2013; 85: 1112–21. 22. Kalman-Szekeres Z, Olajos M, Ganzler K. Analytical aspects of biosimilarity issues of proetin drugs. J Pharm Biomed Anal 2012; 69: 185-95. 23. Harazona A, Hashii N, Kuribayashi R, Nakazawa S, Kawasaki N. Mass spectrometric glycoform profiling of the innovator and biosimilar erythropoietin and darbepoetin by LC/ESI-MS. J Pharm Biomed Anal 2013; 83: 65-74. 24. Holzgrabe U, Nap C, Almeling S. Use of collision induced dissociation mass spectrometry as a rapid technique for the identification of pharmacologically active peptides in pharmacopoeial testing. J Pharm Biomed Anal 2011; 55: 957– 63.
There are 1 citations in total.
Details
| Subjects | Health Care Administration |
|---|---|
| Journal Section | Articles |
| Authors | |
| Publication Date | June 24, 2017 |
| Published in Issue | Year 2017 Volume: 21 Issue: 3 |