Biosimilars
Yıl: 2022 Cilt: 56 Sayı: 1 Sayfa Aralığı: 75 - 76 Metin Dili: İngilizce DOI: 10.4274/turkderm.galenos.2022.06978 İndeks Tarihi: 18-07-2022
Biosimilars
Öz: For a drug to be defined as a biosimilar, it should be fairly similar to the previously approved original or reference product. The minor variances
in its inactive ingredients should not pose clinically significant differences from the reference product in terms of safety and efficacy potency.
Biosimilars of infliximab and adalimumab have received reimbursements in our country. By lowering treatment costs, biosimilars may provide
considerable economies for health systems that reimburse healthcare expenditures.
Anahtar Kelime: Biyobenzerler
Öz: Bir ilacın biyobenzer olarak tanımlanabilmesi için önceden onaylı orijinal veya referans ürüne oldukça benzer olması, inaktif bileşenlerindeki minör
farklılıkların güvenlik, etkinlik ve potens açısından referans ürünle klinik olarak anlamlı farklılıklar yaratmaması gerekir. Ülkemizde infliksimab ve
adalimumabın biyobenzerleri geri ödeme almıştır. Biyobenzerler tedavi maliyetini düşürerek geri ödeme sağlayan sağlık sistemlerinde önemli
bir ekonomi sağlayabilirler
Anahtar Kelime: Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık
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- 3. Kuhlmann M, Covic A: The protein science of biosimilars. Nephrol Dial Transplant 2006;21(Suppl5):v4-8.
- 4. Expert Committee on Biological Standardization. Guidelines on evaluation of similar biotherapeutic products (SBPs) 2009. Available form: http://www. who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_ FOR_WEB_22APRIL2010.pdf
- 5. Committee for Medicinal Products for Human Use (CHMP). (2014). Guideline on similar biological medicinal products containing biotechnology-derived pro- teins as active substance: non-clinical and clinical issues. Available form: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_ guideline/2015/01/WC 500180219.pdf
- 6. Reynolds KA, Pithadia DJ, Lee EB, Han G, Wu JJ: Are biosimilars approved for use in psoriasis safe enough to replace leading biologic therapies? A review. Expert Opin Drug Saf 2020;19:459-66.
- 7. Akyol M, Alper S, Atakan N, et al.: Türkiye Psoriasis Tedavi Kılavuzu. Turkderm - Arch Turk Dermatol Venerol 2016;50(Suppl1):1-56.
- 8. Cohen AD, Wu JJ, Puig L, et al.: Biosimilars for psoriasis: worldwide overview of regulatory guide- lines, uptake and implications for dermatology clinical practice. Br J Dermatol 2017;177:1495-502
| APA | BÜLBÜL BASKAN E (2022). Biosimilars. , 75 - 76. 10.4274/turkderm.galenos.2022.06978 |
| Chicago | BÜLBÜL BASKAN EMEL Biosimilars. (2022): 75 - 76. 10.4274/turkderm.galenos.2022.06978 |
| MLA | BÜLBÜL BASKAN EMEL Biosimilars. , 2022, ss.75 - 76. 10.4274/turkderm.galenos.2022.06978 |
| AMA | BÜLBÜL BASKAN E Biosimilars. . 2022; 75 - 76. 10.4274/turkderm.galenos.2022.06978 |
| Vancouver | BÜLBÜL BASKAN E Biosimilars. . 2022; 75 - 76. 10.4274/turkderm.galenos.2022.06978 |
| IEEE | BÜLBÜL BASKAN E "Biosimilars." , ss.75 - 76, 2022. 10.4274/turkderm.galenos.2022.06978 |
| ISNAD | BÜLBÜL BASKAN, EMEL. "Biosimilars". (2022), 75-76. https://doi.org/10.4274/turkderm.galenos.2022.06978 |
| APA | BÜLBÜL BASKAN E (2022). Biosimilars. Türkderm Türk deri hastalıkları ve frengi arşivi, 56(1), 75 - 76. 10.4274/turkderm.galenos.2022.06978 |
| Chicago | BÜLBÜL BASKAN EMEL Biosimilars. Türkderm Türk deri hastalıkları ve frengi arşivi 56, no.1 (2022): 75 - 76. 10.4274/turkderm.galenos.2022.06978 |
| MLA | BÜLBÜL BASKAN EMEL Biosimilars. Türkderm Türk deri hastalıkları ve frengi arşivi, vol.56, no.1, 2022, ss.75 - 76. 10.4274/turkderm.galenos.2022.06978 |
| AMA | BÜLBÜL BASKAN E Biosimilars. Türkderm Türk deri hastalıkları ve frengi arşivi. 2022; 56(1): 75 - 76. 10.4274/turkderm.galenos.2022.06978 |
| Vancouver | BÜLBÜL BASKAN E Biosimilars. Türkderm Türk deri hastalıkları ve frengi arşivi. 2022; 56(1): 75 - 76. 10.4274/turkderm.galenos.2022.06978 |
| IEEE | BÜLBÜL BASKAN E "Biosimilars." Türkderm Türk deri hastalıkları ve frengi arşivi, 56, ss.75 - 76, 2022. 10.4274/turkderm.galenos.2022.06978 |
| ISNAD | BÜLBÜL BASKAN, EMEL. "Biosimilars". Türkderm Türk deri hastalıkları ve frengi arşivi 56/1 (2022), 75-76. https://doi.org/10.4274/turkderm.galenos.2022.06978 |
