Abstract
ABSTRACT
Biosimilar products are versions of original biotechnological products produced after the patented period of the original products has been filled. Especially the production of biosimilar of biologic drugs used in the treatment of psoriasis and the concept of biosimilars have gained importance in the field of dermatology. For the production of biosimilars, the expiration of the patent period of the original drugs is required. The most important reason for the development of biosimilars is the reduction of the cost. The most important difference between biosimilar is that they are not generic drugs. The most important reason for this is the inability to make individual copies of biological drugs. There is also ambiguity about who owns the biosimilar use decision and in what circumstances the selection can be made.
ÖZET
Biyobenzer ürünler, orijinal ürünlerin patent süresi
dolduktan sonra üretilen orijinal biyoteknolojik ürünlerin versiyonlarıdır. Özelllikle
psoriasis tedavisinde kullanılan biyolojik ilaçların biyobenzerlerinin üretimi
ile biyobenzer kavramı dermatoloji alanında önem kazanmıştır. Biyobenzerlerin
üretimi için orijinal ilaçların patent sürelerinin dolması gereklidir. Biyobenzerlerin geliştirilmesinin en önemli
nedeni maliyetlerin düşürülmesidir. Biyobenzerlerin en önemli farkı jenerik
ilaç olmamalarıdır. Bunun en önemli sebebi ise biyolojik ilaçların birebir
kopyalarının yapılamamasıdır. Biyobenzer kullanım kararının kime ait olduğu,
hangi durumlarda seçimin yapılabileceği ile ilgili de kararsızlıklar vardır.
Keywords
References
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- 7. ClinicalTrials.gov A service of the U.S. National Institutes of Health. 2014. URL https://clinicaltrials.gov/ (last accessed: 23 September 2014.
- 8. Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis 2013; 72: 315-8.
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- 10. Lee H. Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars? AAPS J 2014; 16: 22-6.
- 11. Scott BJ, Klein AV, Wang J. Biosimilar monoclonal antibodies: a Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation. J Clin Pharmacol 2015; 55 Suppl 3: 123-32.
- 12. Feagan BG, Choquette D, Ghosh S et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals 2014; 42: 177-83.
- 13. Puig L. Biosimilars and reference biologics: decisions on biosimilar interchangeability require the involvement of dermatologists. Actas Dermosifiliog 2014; 105: 435-7.
- 14. Ventola CL. Biosimilars. Part 1: Proposed regulatory criteria for FDA approval. P & T. 2013; 38: 270-276.
- 15. Biosimilars: Substitution and Interchangeability. On Amgen website. 2015.
Abstract
References
- 1. Nelson AL et al. Biosimilars. Nat Rev Drug Discov. 2010; 9: 767-74.
- 2. Lonberg N. Biosimilars. Nat Biotechnol. 2005; 23: 1117-25.
- 3. European Medicines Agency recommends approval of first two monoclonal antibody biosimilars. Recommendation marks extension of biosimilar concept to new product-class.URL.http:/www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013.
- 4. GaBI Online – US$54 billion worth of biosimilar patents expiring before 2020 gabionline.net/Biosimilars/Research/US-54-billion-worth-of-biosimilarpatents-expiring-before-2020.
- 5. GaBI: Glossary of key terms. Generics and Biosimilars Initiative website. Updated February 13, 2015.
- 6. Puig L. Biosimilar in Psoriasis 2015: What is next? JEADV 2015: DOI: 10.1111/ jdv.12843.
- 7. ClinicalTrials.gov A service of the U.S. National Institutes of Health. 2014. URL https://clinicaltrials.gov/ (last accessed: 23 September 2014.
- 8. Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis 2013; 72: 315-8.
- 9. Tsiftsoglou AS, Ruiz S, Schneider CK. Development and regulation of biosimilars: current status and future challenges. BioDrugs 2013; 27: 203-11.
- 10. Lee H. Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars? AAPS J 2014; 16: 22-6.
- 11. Scott BJ, Klein AV, Wang J. Biosimilar monoclonal antibodies: a Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation. J Clin Pharmacol 2015; 55 Suppl 3: 123-32.
- 12. Feagan BG, Choquette D, Ghosh S et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals 2014; 42: 177-83.
- 13. Puig L. Biosimilars and reference biologics: decisions on biosimilar interchangeability require the involvement of dermatologists. Actas Dermosifiliog 2014; 105: 435-7.
- 14. Ventola CL. Biosimilars. Part 1: Proposed regulatory criteria for FDA approval. P & T. 2013; 38: 270-276.
- 15. Biosimilars: Substitution and Interchangeability. On Amgen website. 2015.
Details
| Subjects | Health Care Administration |
|---|---|
| Journal Section | Güncel Derlemeler |
| Authors | |
| Publication Date | December 24, 2017 |
| Published in Issue | Year 2017 Volume: 2 Issue: 3 |