The letter states:
Done correctly, an approval process for biosimilars will protect patient safety, expand competition to reduce costs for consumers, and provide fair incentives for continued biomedical innovation.
As well as:
In considering biosimilars legislation, Congress must maintain incentives for continued investment in order to realize the full potential of this sector to provide new therapies and even cures to patients.
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For anyone interested in further reading on the issue of biosimilars, see the Stockholm Network's latest paper in its series on patient safety: Biogenerics or Biosimilars? Discussing the Present, Considering the Future.
In this paper, Rachel Chu and Dr Meir Pugatch explore the issue of biosimilars and their impact on healthcare policymaking. They examine the various challenges that the advent of biosimilars raises, particularly with regard to the regulatory framework, market opportunities, IPRs and most importantly of all, with regard to patient safety.
This paper takes four of the most relevant pathways as case studies, namely the EU, WHO, Canada and the US (where legislation is still under way), and evaluates in particular whether these pathways have resolved the safety and IP dilemmas. Finally, it presents several policy recommendations, which should allow more clarity and predictability for those wishing to enter the market as well as provide enhanced scientific rigour, in the interests of patients.
To view the paper, please visit: http://www.stockholm-network.org/downloads/publications/Biosimilars_FINAL.pdf
To view the executive summary, please visit: http://www.stockholm-network.org/downloads/publications/Biosimilars_Executive Summary.pdf
For further information about the Stockholm Network, please visit: http://www.stockholm-network.org
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