By: Michael Craig, Principal Consultant, PAREXEL Consulting
Fundamentals of EU Regulatory Affairs, Eighth Edition was published in December 2017. The book, published by Regulatory Affairs Professionals Society (RAPS), represents a timely update on the changing regulatory landscape in Europe, covering the implementation of the EU Medical Device Regulation and EU In Vitro Diagnostic Device Regulation. In addition, the impact of the future implementation of the delayed Clinical Trial Regulations is discussed. This latest addition features new chapters as well as updates to existing chapters, including one on generic medicinal products. The chapter on Generic Medicinal Products has been updated to provide further details on the legal basis of generic applications as well as additional information on dissolution data and biowaivers.
The OECD report, ‘Health at a Glance: Europe 2016’ highlighted the prevalence of generics in Europe, noting specifically in the UK that generics accounted for 84% of the volume of pharmaceuticals sold in 2014 - the highest among EU countries - but that this represented only around a third of the total market value. Meanwhile, the use of biosimilar medicines is expected to result in overall savings from 11.8 up to 33.4 billion euros for 8 EU countries between 2007 and 2020. (Medicines for Europe). The importance of generics and biosimilars in the affordable provision of healthcare in Europe is clear and this is reflected by the large number of generic applications received by European regulators.
Given the significance of generic medicines in Europe, PAREXEL Consulting includes dedicated subject-matter experts with significant experience in this area (including one consultant who updated the chapter on generic medicinal products) who are specifically suited to advise pharmaceutical companies (of all sizes) on how to develop generic and biosimilar medicines, strategize on legal basis, advise on bioequivalence data requirements and the demonstration of similarity for biosimilars, and to ultimately submit a successful marketing authorisation application.
PAREXEL is currently supporting clients in running bioequivalence studies and developing regulatory strategies for a variety of small molecule generics and large molecule biosimilars.
[Michael Craig has updated Chapter 28: Generic Medicinal Products of Fundamentals of EU Regulatory Affairs, Eighth Edition
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