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2013 | nr 1 | 84--91
Tytuł artykułu

Biosimilar Drugs - Reimbursement Regulations. Polish ISPOR Chapter's Therapeutic Programs and Pharmaceutical Care (TPPC) Task Force Report

Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
Objectives: Due to the increased number in biosimilar drugs getting marketing authorization, there is a question to be answered which reimbursement procedure should be followed. Methods: The TPPC task force has checked the approach to biosimilar drugs by WHO, at the EMA level and in a few countries worldwide. Among other aspects discussed, we concentrated on the production process of the reference (original) drugs and biosimilars and looked for differences. An internet search was performed checking the definitions as well as regulatory and reimbursement processes worldwide, with focus on the countries having HTA procedure in place. Findings: It was found that due to specifics of biosimilars, detailed and comprehensive regulatory processes have been established centrally for EU states. No reimbursement guidelines have been identified. Due to lack of specific reimbursement guidelines TPPC agreed on a need to define a biosimilar drugs reimbursement process in Poland. TPPC task force also agreed that due to central European registration process the definitions for biosimilar drug in Poland should be in line with the EMA guidelines. The reimbursement process is different in each EU member state and it should be defined for these products on a country level. Probably, it also requires specific guidelines to be developed, especially in countries such as Polandwith "HTA dependent reimbursement process". Conclusions: TPPC task force has only identified regulatory guidelines and its opinion is that in Poland, a detailed reimbursement process should be developed in the way it also includes the biosimilar drugs.(original abstract)
Rocznik
Numer
Strony
84--91
Opis fizyczny
Twórcy
  • Medical University of Lublin, Poland
  • Roche Polska Sp. z o.o., Warsaw, Poland
Bibliografia
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  • Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use; Official Journal of the European Union L 348; 31.12.2010
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  • Saudi Food and Drug Authority: Biosimilar Guidelines Saudi Arabia. Available from: http://www.sfda.gov.sa/NR/rdonlyres/CB28C6AF-79CD-4412-8801-35AEDEED0183/0/Guidelinesonbiosimilars_v11.pdf; [Accessed: 29 November 2012]
  • Turkish Pharmaceuticals and Pharmacy General Directorate: Biosimilar Medicinal Products Guide. Available from: http://www.iegm.gov.tr/Folders/TheLaws/Biobenzer Kilavuzu,07.08.2008,Eng.4621062.pdf; [Accessed: 29 November 2012]
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  • Soo Kyung Suh, Younjoo Park: Regulatory guideline for biosimilar products in Korea, Biologicals 39 (2011); 336-338
Typ dokumentu
Bibliografia
Identyfikatory
Identyfikator YADDA
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