Key concepts in biosimilar medicines: What physicians must know
Yıl: 2022 Cilt: 9 Sayı: 1 Sayfa Aralığı: 86 - 91 Metin Dili: İngilizce DOI: 10.14744/nci.2021.84669 İndeks Tarihi: 21-06-2022
Key concepts in biosimilar medicines: What physicians must know
Öz: Biologics’ are a class of medications produced by living cells using recombinant DNA technology. Biologics have had an important
impact in many areas of medicine, and in particular in rheumatology and oncology. However, the high cost of these
agents is a growing concern, particularly as more products become available and their use for the treatment of immunemediated
inflammatory diseases continues to expand. Biosimilars, also called follow-on biologics, have been viewed as a potential
cost-saving alternative to traditional therapies. Currently, a product can be considered biosimilar to a reference product
if there are no clinically meaningful differences in terms of safety, purity, and potency. In this review, the most important key
concepts about biosimilars were summarized for physicians emphasizing the status in Turkey.
Anahtar Kelime: Belge Türü: Makale Makale Türü: Derleme Erişim Türü: Erişime Açık
- 1. Tsiftsoglou AS, Ruiz S, Schneider CK. Development and regulation of biosimilars: current status and future challenges. BioDrugs 2013;27:203–11.
- 2. Thorpe R, Wadhwa M. Intended use of reference products & WHO International Standards/Reference Reagents in the development of similar biological products (biosimilars). Biologicals 2011;39:262–5.
- 3. European Medicines Agency. Evaluation of Medicines for Human Use: Available at: http://www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2009/09/WC500003517.pdf. Accessed Jan 07, 2022.
- 4. European Medicine Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on non-clinical and clinical development of similar biological medicinal products.
- 5. World Health Organization. Expert committee on biological standardization. Available at: http://www.who.int/biologicals/areas/biological_ therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010. pdf. Accessed Jan 07, 2022.
- 6. European Medicine Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on non-clinical and clinical development of similar biological medicinal products.
- 7. European Commission, Enterprise and ındustry directorate-general. Consensus Information Paper 2013. What you need to know about Biosimilar Medicinal Products. 2013. Available at: https://www.medicinesforeurope. com/2015/02/22/test-article-p/. Accessed Feb 7, 2014.
- 8. Schellekens H. Immunogenicity of therapeutic proteins. Nephrol Dial Transplant 2003;18:1257–9.
- 9. Knezevic I, Griffiths E. Biosimilars-global issues, national solutions. Biologicals 2011;39:252–5.
- 10. GaBI Online - Generics and Biosimilars Initiative. Biosimilars in EU to be identified by brand names. Available at: www.gabionline.net/Policies- Legislation/Biologicals-in-EU-to-be-identified-by-brandnames. Accessed Jan 10, 2022.
- 11. İskit AB. Biyobenzerler. OnkoBülten. 2014 August: 6–9.
- 12. Iskit AB. Products situation of the biosimiliars in Turkey and in the world. 5th International Eurasian Hematology Congress, Antalya, Turkey, 15-19 October. Leukemia Research 2014;38:SP–017.
- 13. Biyobenzer tıbbi ürünler hakkında kılavuz. Available at: https:// titck.gov.tr/storage/Archive/2021/contentFile/Biyobenzer%20 K%C4%B1lavuzu_c25fed2f-d042-4622-84ec-93c0b135c1cf.pdf. Accessed Jan 10, 2022.
- 14. İskit AB. Biyobenzer kavramı ve Türkiye’de biyobenzerler. Sürekli Tıp Eğitimi Dergisi 2016;25:28–33.
- 15. İskit AB, Çiçin İ. Referans ürünle yeterli karşılaştırma çalışması olmayan biyolojik ürünler. In: Biyoteknolojik İlaçlar. 1st ed. İstanbul: Araştırmacı İlaç Firmaları Derneği-AIFD Yayını; 2020.
| APA | Iskit A (2022). Key concepts in biosimilar medicines: What physicians must know. , 86 - 91. 10.14744/nci.2021.84669 |
| Chicago | Iskit Alper B. Key concepts in biosimilar medicines: What physicians must know. (2022): 86 - 91. 10.14744/nci.2021.84669 |
| MLA | Iskit Alper B. Key concepts in biosimilar medicines: What physicians must know. , 2022, ss.86 - 91. 10.14744/nci.2021.84669 |
| AMA | Iskit A Key concepts in biosimilar medicines: What physicians must know. . 2022; 86 - 91. 10.14744/nci.2021.84669 |
| Vancouver | Iskit A Key concepts in biosimilar medicines: What physicians must know. . 2022; 86 - 91. 10.14744/nci.2021.84669 |
| IEEE | Iskit A "Key concepts in biosimilar medicines: What physicians must know." , ss.86 - 91, 2022. 10.14744/nci.2021.84669 |
| ISNAD | Iskit, Alper B.. "Key concepts in biosimilar medicines: What physicians must know". (2022), 86-91. https://doi.org/10.14744/nci.2021.84669 |
| APA | Iskit A (2022). Key concepts in biosimilar medicines: What physicians must know. İstanbul Kuzey Klinikleri, 9(1), 86 - 91. 10.14744/nci.2021.84669 |
| Chicago | Iskit Alper B. Key concepts in biosimilar medicines: What physicians must know. İstanbul Kuzey Klinikleri 9, no.1 (2022): 86 - 91. 10.14744/nci.2021.84669 |
| MLA | Iskit Alper B. Key concepts in biosimilar medicines: What physicians must know. İstanbul Kuzey Klinikleri, vol.9, no.1, 2022, ss.86 - 91. 10.14744/nci.2021.84669 |
| AMA | Iskit A Key concepts in biosimilar medicines: What physicians must know. İstanbul Kuzey Klinikleri. 2022; 9(1): 86 - 91. 10.14744/nci.2021.84669 |
| Vancouver | Iskit A Key concepts in biosimilar medicines: What physicians must know. İstanbul Kuzey Klinikleri. 2022; 9(1): 86 - 91. 10.14744/nci.2021.84669 |
| IEEE | Iskit A "Key concepts in biosimilar medicines: What physicians must know." İstanbul Kuzey Klinikleri, 9, ss.86 - 91, 2022. 10.14744/nci.2021.84669 |
| ISNAD | Iskit, Alper B.. "Key concepts in biosimilar medicines: What physicians must know". İstanbul Kuzey Klinikleri 9/1 (2022), 86-91. https://doi.org/10.14744/nci.2021.84669 |
