Search results for: Biosimilars
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What is the Role of HTA for Biosimilars?
1 April 2014
…for biosimilars in the UK. It reports on the roundtable’s deliberations about when HTA for biosimilars is needed and which approaches are most appropriate in specific situations. The roundtable’s caution…
Spotlight on OHE: NICE, Biosimilars, HTA
17 June 2014
…UK HTA agencies, the MHRA and academia were involved in debating which HTA methods are most appropriate for biosimilars in specific situations. The Role of HTA for Biosimilars Mestre-Ferrandiz 2014…
The Market for Biosimilars
25 January 2011
…for biosimilars and the implications of these for potential savings. Economists and regulatory experts from the US and Europe were invited to describe their research and offer their perspectives about what…
Biosimilars: How Much Entry and Price Competition Will Result?
1 December 2010
This publication reports on a seminar intended to encourage further thought about the distinguishing characteristics of the market for biosimilars and the implications of these for potential savings. Economists and…
The Market for Biosimilars: Evolution and Policy Options
1 November 2008
…approval. Clinicians will require “patient safety year” (PSY) evidence after approval, according to the authors, that shows the equivalence in efficacy and safety of biosimilars as used in practice. Governments…
Biosimilar Competition: Lessons from Europe and Prospects for the US
2 December 2014
…to encourage biosimilars, and physicians will become more experienced with them. Download Grabowski, H., 2014. Biosimilars Competition: Lessons from Europe and Prospects for the US. London: Office of Health…
Biosimilar Competition: Lessons from Europe and Prospects for the US
1 October 2014
Based on an OHE lunchtime seminar by Professor Henry Grabowski, this seminar briefing explores the lessons learned from Europe’s experience with biosimilars, and provides an analysis of how the US…
Drug shortages are on the rise – but what is their impact?
16 September 2024
…shortages occur most significantly in markets of off-patent generic medicines and biosimilars. This is mainly the result of cost containment policies resulting in heavy price erosion and commercially unattractive markets…
Review of CRA’s Report “Assessing the Economic Impacts of Changing Exemption Provisions During Patent and SPC Protection in Europe”
1 January 2018
The CRA Report has an underlying assumption that the EU is as globally competitive in generics and biosimilars as it is in innovative products. There is no evidence to support…