Výsledky vyhledávání - "Michael S Reilly"

A critical review of substitution policy for biosimilars in Canada

Autor: Michael S Reilly, Philip J Schneider

Publikováno v: Generics and Biosimilars Initiative Journal. 10:123-129

Canada has approved a total of 36 biosimilars. While the approval of biosimilars is regulated at the national level, decisions about biosimilar substitution are made at the provincial level. Four Canadian provinces, representing around 50% of the pop

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::5a2234588d6edd50e9336cd76f0ee18e
https://doi.org/10.5639/gabij.2021.1003.016

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A white paper: US biosimilars market on pace with Europe

Autor: Michael S Reilly, Madelaine Feldman

Publikováno v: Generics and Biosimilars Initiative Journal. 9:150-154

In the US, 28 biosimilars have been approved, with 10 in the last two years. The US is keeping pace with the EU who pioneered biosimilars approvals a decade earlier. Herein, current FDA regulations and hurdles encountered for US biosimilar approval a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::a0b63484ea9ade82d58173e05fdd9475
https://doi.org/10.5639/gabij.2020.0904.025

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European prescribers’ attitudes and beliefs on biologicals prescribing and automatic substitution

Autor: Madelaine Feldman, Michael S Reilly

Publikováno v: Generics and Biosimilars Initiative Journal. 9:116-124

Introduction: The European Union (EU) and the European Medicines Agency (EMA) have led the development of a regulatory framework for biosimilars since 2004. By end of December 2019, 64 biosimilars of 15 originator biological medicines have a marketin

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::29eea4354ba302e5a092f5114dad9f80
https://doi.org/10.5639/gabij.2020.0903.020

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Policy recommendations for a sustainable biosimilars market: lessons from Europe

Autor: Philip J Schneider, Michael S Reilly

Publikováno v: Generics and Biosimilars Initiative Journal. 9:76-83

Approximately 25% of all new medicines approved in recent years and in development today are biologicals. The complexity of biologicals, the investment needed to meet ever more stringent regulatory and payer requirements, combined with the needs of a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::d0013718756879b64992a34dc3c3263c
https://doi.org/10.5639/gabij.2020.0902.013

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