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Autor
Drozd Mariola (Department of Applied Pharmacy, Medical University of Lublin), Szkultecka-Dębek Monika (Roche Polska Sp. z o.o., Warsaw, Poland), Baran-Lewandowska Izabela (Department of Pharmacoeconomics, Medical University of Warsaw)
Tytuł
Biosimilar Drugs - Automatic Substitution Regulations Review. Polish ISPOR Chapter's Therapeutic Programs and Pharmaceutical Care (TPPC) Task Force Report
Źródło
Journal of Health Policy and Outcomes Research, 2014, nr 1, s. 52-57, tab., bibliogr. 23 poz.
Słowa kluczowe
Regulacje prawne, Rynek farmaceutyczny
Legal regulations, Pharmaceutical market
Uwagi
summ.
Abstrakt
Objectives: Review of the EU regulations concerning substitution of biological products with biosimilar products . Methods: The TPPC task force has checked the approach to automatic substitution by WHO, at the EMA level and in countries across European Union. An internet search was performed checking the regulations and direct contact to Regulatory Agencies in all European Union member states. Results: Based on the research we have obtained directly information from 23 EU Member States and Switzerland. Most of the EU countries do not allow for automatic substitution of the reference biological medicinal product by a biosimilar. Currently some EU countries already have local legal regulations towards automatic substitution of medicinal products in place. Conclusions: Due to medicinal product complexity in most of the European Union countries the automatic substitution of a reference biological product by a biosimilar product is not allowed. Local regulations are needed in each of the Member States according to EMA guidance(original abstract)
Pełny tekst
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Bibliografia
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  2. European Commission: What you need to know about biosimilar medical products. Available from: http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf; [Accessed: 23.01.2014]
  3. Expert Committee on Biological Standardization WHO: Guidelines on evaluation of similar biotherapeutic products (SBPs). Geneva 19-23 October 2009. Available from: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf; [Accessed: 10.02.2014]
  4. European Medicines Agency: EMA Procedural advice for users of the centralised procedure for similar biological medicinal products applications. EMA/940451/2011, March 2013. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/04/WC500125166.pdf; [Accessed: 23.01.2014]
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  6. EMA, 2006: Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf; [Accessed: 10.12.2013]
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  14. Finnish Medicines Agency: Criteria used in compiling the list. Principles for compiling the list of mutually substitutable medicinal products with marketing authorisation at the Finnish Medicines Agency. Available from: http://www.fimea.fi/medicines/substitutable_medicinal_products/criteria_used_in_compiling_the_list; National laws. Available from: http://www.fimea.fi/national_laws; [Accessed: 27.01.2014]
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  17. Norwegian Miedicines Agency: Biosimilars: The Norwegian Medicines Agency (NOMA) suggests legislative amendment. Available from: http://www.legemiddelverket.no/Nyheter/Blaa_resept_og_pris/Documents/2012-11 November/English summary.pdf; [Accessed: 5.02.2014]
  18. Swedish medical Products Agency: Comments on the List of Substitutable Medicinal Products. Available from: http://www.lakemedelsverket.se/english/product/Medicinal-products/Substitution/; [Accessed: 4.02.2014]
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  23. Karst K.R. The Biosimilars State Legislation Scorecard. Available from: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/09/biosimilars-state-legislation-scorecard.html; [Accessed: 13.02.2014]
Cytowane przez
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ISSN
2299-1247
Język
eng
URI / DOI
http://dx.doi.org/10.7365/JHPOR.2014.5.5
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