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

• Autorzy: Mariola Drozd , Monika Szkultecka-Dębek , Izabela Baran-Lewandowska
• Języki publikacji: EN

Abstrakty

EN

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)

Słowa kluczowe

EN

Legal regulations; Pharmaceutical market

PL

Regulacje prawne; Rynek farmaceutyczny

• Czasopismo: Journal of Health Policy and Outcomes Research
• Rocznik: 2014
• Numer: nr 1
• Strony: 52--57

Twórcy

autor

Mariola Drozd

• Department of Applied Pharmacy, Medical University of Lublin

autor

Monika Szkultecka-Dębek

• Roche Polska Sp. z o.o., Warsaw, Poland

autor

Izabela Baran-Lewandowska

• Department of Pharmacoeconomics, Medical University of Warsaw

Bibliografia

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Identyfikatory

DOI

10.7365/JHPOR.2014.5.5