Jenerik ilaç, referans alınan orijinal ilaç ile aynı etkin maddeyi aynı dozda aynı ya da benzer farmasötik şekilde içeren ve orijinal ilacın patent koruma süresi bittikten sonra üretilebilen ilaçtır. 1984 yılında yürürlüğe giren 'Hatch-Waxman Hareketi' olarak bilinen 'İlaç Fiyat Rekabeti ve Patent Yenileme Kanunu' ile jenerik ilaçların kullanımının yaygınlaşmasında, preklinik ve klinik faz çalışması koşulunun jenerik ilaçların ruhsat başvuru sürecinden çıkarılarak 'kısaltılmış yeni ilaç başvurusu' hâline getirilmesi etkili olmuştur. Sınırlı sayıda sağlıklı gönüllü ile yapılan biyoyararlanım/biyoeşdeğerlik çalışmaları ile jenerik ilacın referans ile terapötik eşdeğer olduğunun gösterilmesi yeterli olarak kabul edilir. Bu nedenle daha düşük maliyet ile piyasaya çıkan jenerikler referans ilaçlara göre genellikle daha ucuzdur. Bu sayede jenerikler, sağlık hizmeti kalitesinden ödün vermeden ilaç harcamalarının azaltılmasına kritik katkı sağlar. Nitekim özellikle gelişmiş ülkelerde, jenerik ilaçların kullanımının yaygınlaştırılması ile ilaçların sağlık bütçesinde meydana getirdiği baskının azaltılması amaçlanmış ve bu doğrultuda özel politikalar uygulanmaya başlanmıştır. Jenerik kullanımının yaygınlaştırılmasında, uygulanan idari politikalarının yanı sıra tüketicilerin, eczacıların ve hekimlerin jenerik ilaçlar ile ilgili algıları ve davranışları, tanıya ve ilaca ilişkin özellikler vb. faktörler de etkili olabilmektedir. Bu derlemede, jenerik ilaçlara yönelik temel bilgilere yer verilmesi ve farklı yerlerde kullanımı gittikçe yaygınlaşmakta olan bu ilaçlara ilişkin dünyadaki ve Türkiye'deki gelişmelerin sunulması amaçlanmıştır.
Anahtar Kelimeler: Jenerik ilaç; orijinal; ilaç kullanımı; biyoeşdeğerlik
The generic drug contains the same active substance as the referenced original drug, in the same dose, in the same or similar pharmaceutical form and can be produced after the patent protection period of the original drug expires. With "The Drug Price Competition and Patent Term Restoration Act", informally known as the 'Hatch-Waxman Act' in 1984, the requirement for pre-clinical and clinical phase studies was abolished in the approval process of generics. In this context, replacement of the former process with the "abbreviated new drug application" has streamlined the widespread use of generics. Generic drug is deemed as therapeutically equivalent to reference product by demonstrating bioequivalence through bioavailability/bioequivalence studies conducted with a limited number of healthy volunteers. Therefore, generic drugs introduced to the market with lower costs are generally cheaper than reference drugs. In this way, generic drugs make a critical contribution to reducing drug expenditures without conceding healthcare quality. In fact, especially in developed countries, it was aimed to off-load the pressure caused by drug costs on the health budget via increasing the use of generic drugs, and special policies have been implemented. Apart from administrative policies, many factors including consumers', pharmacists', and physicians' perceptions and behaviors about generics, diagnosis and drug-related characteristics, etc. can impact in spreading the use of generic drugs. In this review, it was aimed to provide fundamental information about generic drugs and present the developments in the world and in Turkey for these drugs which are becoming more widespread.
Keywords: Generic drug; original; drug utilization; bioequivalence
- Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH, Patel DT, et al. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother. 2009;43(10):1583-97. [Crossref] [PubMed]
- Chow SC. Bioavailability and Bioequivalence in Drug Development. Wiley Interdiscip Rev Comput Stat. 2014;6(4):304-312. [Crossref] [PubMed] [PMC]
- Resmî Gazete (19.01.2005, Sayı: 25705) Beşeri Tıbbi Ürünler Ruhsatlandırma Yönetmeliği.
- Resmî Gazete (27.05.1994. Sayı: 21942) Farmasötik Müstehzarların Biyoyararlanım ve Biyoeşdeğerliliğinin Değerlendirilmesi Hakkında Yönetmelik.
- Food and Drug Administratiton (FDA) [İnternet]. [Erişim Tarihi: 23.12.2020]. Office of Generic Drugs 2019 Annual Report. Ensuring access to safe, affordable, and effective generic drugs. 2020. Erişim linki: [Link]
- Hornecker JR. Generic drugs: history, approval process, and current challenges. US Pharm. 2009;34(6):26-30. [Link]
- Ascione FJ, Kirking DM, Gaither CA, Welage LS. Historical overview of generic medication policy. J Am Pharm Assoc (Wash). 2001;41(4):567-77. [Crossref] [PubMed]
- Kesselheim AS, Misono AS, Lee JL, Stedman MR, Brookhart MA, Choudhry NK, et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008;300(21):2514-26. [Crossref] [PubMed] [PMC]
- Lofgren H. Generic drugs: international trends and policy developments in Australia. Aust Health Rev. 2004;27(1):39-48. [Crossref] [PubMed]
- Association for Accessible Medications [İnternet]. ©2020 Association for Accessible Medicines [Erişim tarihi: 23.12.2020]. Generic drug access & savings in the US. 2017. Erişim linki: [Link]
- Bak B. İlaçta zorunlu patent lisansı [Compulsory patent licensing for pharmaceuticals]. Ankara Barosu Dergisi, 2011;3:105-126.
- Arafat M, Ahmed Z, Arafat O. Comparison between generic drugs and brand name drugs from bioequivalence and thermoequivalence prospective. Int. J. Pharm. Pharm. 2017;9(6):1-4. [Crossref]
- Razmaria AA. Generic drugs. JAMA. 2016;315(24):2746. [Crossref]
- Food and Drug Administration (FDA) [İnternet]. [Erişim tarihi: 23.12.2020]. Center for Drug Evaluation and Research (CDER) Guidance for Industry. Submission of summary bioequivalence data for ANDAs. May 2011. Generics. Erişim linki: [Link]
- European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on the investigation of bioequivalence. CPMP/EWP/QWP/1401/98, 2010. [Link]
- Davit B, Braddy AC, Conner DP, Yu LX. International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences. AAPS J. 2013;15(4):974-90. [Crossref] [PubMed] [PMC]
- Berg MJ, Gross RA, Tomaszewski KJ, Zingaro WM, Haskins LS. Generic substitution in the treatment of epilepsy: case evidence of breakthrough seizures. Neurology. 2008;71(7):525-30. [Crossref] [PubMed]
- Liow K, Barkley GL, Pollard JR, Harden CL, Bazil CW; American Academy of Neurology. Position statement on the coverage of anticonvulsant drugs for the treatment of epilepsy. Neurology. 2007;68(16):1249-50. [Crossref] [PubMed]
- Milligan PE, Banet GA, Waterman AD, Gatchel SK, Gage BF. Substitution of generic warfarin for Coumadin in an HMO setting. Ann Pharmacother. 2002;36(5):764-8. [Crossref] [PubMed]
- Lee HL, Kan CD, Yang YJ. Efficacy and tolerability of the switch from a branded to a generic warfarin sodium product: an observer-blinded, randomized, crossover study. Clin Ther. 2005;27(3):309-19. [Crossref] [PubMed]
- Jiang W, Makhlouf F, Schuirmann DJ, Zhang X, Zheng N, Conner D, et al. A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion. AAPS J. 2015;17(4):891-901. Erratum in: AAPS J. 2015;17(6):1519. [Crossref] [PubMed] [PMC]
- Dunne S, Shannon B, Dunne C, Cullen W. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacol Toxicol. 2013;14:1. [Crossref] [PubMed] [PMC]
- T.C. Sağlık Bakanlığı. Beşeri Tıbbi Ürünlerin Biyoyararlanım ve Biyoeşdeğerliğinin İncelenmesi Hakkında Kılavuz Taslağı, 2019. [Link]
- Wouters OJ, Kanavos PG, McKEE M. Comparing Generic Drug Markets in Europe and the United States: Prices, Volumes, and Spending. Milbank Q. 2017;95(3):554-601. [Crossref] [PubMed] [PMC]
- IMS Institute for Healthcare Informatics. The role of generic medicines in sustaining healthcare systems: a European perspective, 2015. [Link]
- Rémuzat C, Urbinati D, Mzoughi O, El Hammi E, Belgaied W, Toumi M. Overview of external reference pricing systems in Europe. J Mark Access Health Policy. 2015;3. [Crossref] [PubMed] [PMC]
- Kumru S, Top M. İlaç fiyatlandırma ve geri ödeme politikalarının orijinal ilaç ve jenerik ilaç açısından değerlendirilmesi: Hipertansiyon ilaçları örneği [Evaluation of Pharmaceutical Pricing and Reimbursement Policies with Regard To Original Drug and Generic Drug: A Case of Hypertension Drugs]. Hacettepe Sağlık İdaresi Dergisi. 2017;20(2):125-141. [Link]
- Resmî Gazete (29.09.2017, Sayı: 30195) Beşeri Tıbbi Ürünlerin Fiyatlandırılması Hakkında Tebliğ. [Link]
- İlaç Endüstrisi İşverenler [İnternet]. [Erişim tarihi: 23.12.2020]. Türkiye ilaç sektörü 2015. Erişim linki: [Link]
- Drummond M, Jönsson B, Rutten F. The role of economic evaluation in the pricing and reimbursement of medicines. Health Policy. 1997;40(3):199-215. [Crossref] [PubMed]
- Mylan [İnternet]. [Erişim tarihi: 23.12.2020]. A Legacy of Impact 2019 Global Social Responsibility Report. May 2020. Erişim linki: [Link]
- Howard JN, Harris I, Frank G, Kiptanui Z, Qian J, Hansen R. Influencers of generic drug utilization: A systematic review. Res Social Adm Pharm. 2018;14(7):619-627. [Crossref] [PubMed] [PMC]
- Organisation for Economic Co-operation and Development (OECD). Strategies to reduce wasteful spending: turning the lens to hospitals and pharmaceuticals, in Health at a Glance: Europe 2018: State of Health in the EU Cycle, OECD Publishing, Paris/European Union, Brussels. [Link]
- Zuidberg C, Vogler S, Mantel A. The pharmaceutical system of the Netherlands. A comparative analysis between the Dutch out-patient pharmaceutical system, in particular the pricing and reimbursement characteristics, and those of the other European Union Member States, with a special focus on tendering-like systems, 2010. [Link]
- Babar ZUD, Ramzan S, El-Dahiyat F, Tachmazidis I, Adebisi A, Hasan SS. The availability, pricing and affordability of essential diabetes medicines in 17 low-, middle-and high-income countries. Front Pharmacol. 2019;10:1375. [Crossref]
- Kjoenniksen I, Lindbaek M, Granas AG. Patients' attitudes towards and experiences of generic drug substitution in Norway. Pharm World Sci. 2006;28(5):284-9. [Crossref] [PubMed]
- Colgan S, Faasse K, Martin LR, Stephens MH, Grey A, Petrie KJ. Perceptions of generic medication in the general population, doctors and pharmacists: a systematic review. BMJ Open. 2015;5(12):e008915. [Crossref] [PubMed] [PMC]
- Tahirler P, Öncü Ş, Arıcı MA, Uçku R, Gelal A. Bir üniversite hastanesinde çalışan tıpta uzmanlık öğrencilerinin eşdeğer ilaçlar hakkında bilgi, düşünce ve tutumlarının değerlendirilmesi [Evaluation of the knowledge, perception and attitude of residents in medicine working in a university hospital about generic drugs]. DEÜ Tıp Fakültesi Dergisi. 2019;33(2):109-119. [Crossref]
- Mondelo-García C, Mendoza E, Movilla-Fernández MJ, Coronado C. Perceptions of pharmacists and physicians on generic substitution in a financial crisis context in Northwestern Spain: A qualitative study. Health Policy. 2018;122(12):1316-25. [Crossref] [PubMed]
- Toverud EL, Hartmann K, Håkonsen H. A Systematic Review of Physicians' and Pharmacists' Perspectives on Generic Drug Use: What are the Global Challenges? Appl Health Econ Health Policy. 2015;13 Suppl 1(Suppl 1):S35-45. [Crossref] [PubMed] [PMC]
- Toklu HZ, Dülger GA, Hıdıroğlu S, Akici A, Yetim A, Gannemoğlu HM, et al. Knowledge and attitudes of the pharmacists, prescribers and patients towards generic drug use in Istanbul - Turkey. Pharm Pract (Granada). 2012;10(4):199-206. [Crossref] [PubMed] [PMC]
- Bilgener E, Özçelikay G. A survey to evaluate the opinions of Turkish physicians' on bioequivalence. Turk J Pharm Sci. 2007;4(2):79-87. [Link]
- Resmî Gazete (18.06.2009, Sayı: 43081) Sağlık Bakanlığı, İlaç ve Eczacılık Genel Müdürlüğü Eşdeğer ilaç kullanımı. [Link]
- Awaisu A, Kheir N, Ibrahim MI, El-Hajj M, Hazi H, Khudair N, et al. Knowledge, attitudes, and practices of community pharmacists on generic medicines in Qatar. Int J Clin Pharm. 2014;36(2):394-404. [Crossref] [PubMed]
- Segal JB, Onasanya O, Daubresse M, Lee CY, Moechtar M, Pu X, et al. Determinants of Generic Drug Substitution in the United States. Ther Innov Regul Sci. 2020;54(1):151-7. [Crossref] [PubMed] [PMC]
- Panteli D, Arickx F, Cleemput I, Dedet G, Eckhardt H, Fogarty E, et al. Pharmaceutical regulation in 15 European countries review. Health Syst Transit. 2016;18(5):1-122. [PubMed]
- Allenet B, Barry H. Opinion and behaviour of pharmacists towards the substitution of branded drugs by generic drugs: survey of 1,000 French community pharmacists. Pharm World Sci. 2003;25(5):197-202. [Crossref] [PubMed]
- Babar ZU, Stewart J, Reddy S, Alzaher W, Vareed P, Yacoub N, et al. An evaluation of consumers' knowledge, perceptions and attitudes regarding generic medicines in Auckland. Pharm World Sci. 2010;32(4):440-8. [Crossref] [PubMed]
- Miller DP, Mansfield RJ, Woods JB, Wofford JL, Moran WP. The impact of drug samples on prescribing to the uninsured. South Med J. 2008;101(9):888-93. [Crossref] [PubMed]
- Shrank WH, Cox ER, Fischer MA, Mehta J, Choudhry NK. Patients' perceptions of generic medications. Health Aff (Millwood). 2009;28(2):546-56. [Crossref] [PubMed] [PMC]
- Mattioli F, Siri G, Castelli F, Puntoni M, Zuccoli ML, Stimamiglio A, et al. Approval rating and opinion of outpatients and general practitioners toward generic drugs: a questionnaire-based real-world study. Patient Prefer Adherence. 2017;11:1423-33. [Crossref] [PubMed] [PMC]
- Xanthopoulou SS, Katsaliaki K. Policies and perceptions on generic drugs: The case of Greece. Health Serv Manage Res. 2019;32(1):49-56. [Crossref] [PubMed]
- Briesacher BA, Andrade SE, Fouayzi H, Chan KA. Medication adherence and use of generic drug therapies. Am J Manag Care. 2009;15(7):450-6. [PubMed] [PMC]
- Hassali MA, Kong DCM, Stewart K. Generic medicines: perceptions of consumers in Melbourne, Australia. Int J Pharm Pract. 2005;13(4):257-264. [Crossref]
- Chong CP, March G, Clark A, Gilbert A, Hassali MA, Bahari MB. A nationwide study on generic medicines substitution practices of Australian community pharmacists and patient acceptance. Health Policy. 2011;99(2):139-48. [Crossref] [PubMed]
- Villarroel-Stuart AR. Investigation of the national drug lists and the perception of pharmacists and physicians about generic drugs at health institutions in the north central region of Trinidad. 2018. [Crossref]
- Tuncay B, Pagano S, De Santis M, Cavallo P. Prescribing Behavior of General Practitioners for Generic Drugs. Int J Environ Res Public Health. 2020;17(16):5919. [Crossref] [PubMed] [PMC]
- World Health Organization (WHO). How to investigate drug use in health facilities. Selected drug use indicators. Geneva: WHO; 1993. [Link]
- Carone G, Schwierz C, Xavier A. Cost-containment policies in public pharmaceutical spending in the EU. 2012. SSRN 2161803. [Crossref]
- Godman B, Bennie M, Baumgärtel C, Sović-Brkičić L, Burkhardt T, Fürst J et al. Essential to increase the use of generics in Europe tomaintain comprehensive health care? Farmeconomia. Health economics and therapeutic pathways 2012; 13(Suppl 3): 5-20. [Crossref]
- Hassali MA, Alrasheedy AA, McLachlan A, Nguyen TA, Al-Tamimi SK, Ibrahim MI, et al. The experiences of implementing generic medicine policy in eight countries: A review and recommendations for a successful promotion of generic medicine use. Saudi Pharm J. 2014;22(6):491-503. [Crossref] [PubMed] [PMC]
- Malhotra S, Cheriff AD, Gossey JT, Cole CL, Kaushal R, Ancker JS. Effects of an e-Prescribing interface redesign on rates of generic drug prescribing: exploiting default options. J Am Med Inform Assoc. 2016;23(5):891-8. [Crossref] [PubMed]
- Kuribayashi R, Appleton S. Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada. Drugs R D. 2017;17(3):371-9. [Crossref] [PubMed] [PMC]
- T.C. Sağlık Bakanlığı [İnternet]. Sağlık İstatistikleri Yıllığı 2018. Ankara, 2019. [Link]
- Organisation for Economic Co-operation and Development (OECD) [İnternet]. Health at a Glance 2019: OECD Indicators, OECD Publishing, Paris. [Erişim Tarihi: 12 Ağustos 2021]. Erişim linki: [Crossref]
- Gursoy K. Türkiye'de Kamu İlaç Politikaları, İlaç Fiyatlaması ve İlaç Harcamasının Analizi [An analysis of public pharmaceutical policy, pricing and spending in Turkey]. J Soc Sec. 2016;6(1):225-43. [Link]
- Kumru S, Top M. Pricing and reimbursement of generic pharmaceuticals in Turkey: Evaluation of hypertension drugs from 2007 to 2013. Health Policy and Technology. 2018;7(2):182-193. [Crossref]
- Mallam N, Byalakere Rudraiah CS, Rudraswamy S. Generic drugs: current status and future potential. Journal of Generic Medicines. 2017;13(2):54-59. [Crossref]
- Evaluate Pharma World Preview 2020, Outlook to 2026. 13th Edition, July 2020. [Link]
- Eilat E. The inevitable future of generic pharma dugs companies. J Bioequiv Availab 2018;10(3):48-9. [Crossref]
- The Lancet Oncology. Generic drugs: are they the future for affordable medicine? Lancet Oncol. 2018;19(2):149. [Crossref] [PubMed]
- Organisation for Economic Co-operation and Development (OECD) [İnternet]. Pharmaceutical spending trends and future challenges. In: Health at a Glance 2015. OECD, 2015. [Link]
- Food and Drug Administration (FDA) [İnternet]. [Erişim tarihi: 22.12.2020]. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Silver Spring, MD, 2015. Erişim linki: [Link]
- Blackstone EA, Joseph PF. The economics of biosimilars. Am Health Drug Benefits. 2013;6(8):469-78. [PubMed] [PMC]
- Schneider PJ, Reilly MS. Policy recommendations for a sustainable biosimilars market: lessons from Europe. GaBI J. 2020;9(2):76-83. [Crossref]
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