tag:blogger.com,1999:blog-36634196.post7926587174759038249..comments2023-10-09T11:33:37.853-05:00Comments on The IN VIVO Blog: Follow-On Blackjack: Place Your Exclusivity BetsChris Morrisonhttp://www.blogger.com/profile/04075266444951558159noreply@blogger.comBlogger1125tag:blogger.com,1999:blog-36634196.post-88775159361447382412009-10-27T06:31:41.473-05:002009-10-27T06:31:41.473-05:00For anyone interested in further reading on the is...For anyone interested in further reading on the issue of biosimilars, see the Stockholm Network's latest paper in our series on patient safety: Biogenerics or Biosimilars? Discussing the Present, Considering the Future. <br /><br />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 public safety. <br /><br />The 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 providing enhanced scientific rigour, in the interests of patients.<br /><br />To view the paper, please visit:<br />http://www.stockholm-network.org/downloads/publications/Biosimilars_FINAL.pdf <br /><br />To view the executive summary, please visit:<br />http://www.stockholm-network.org/downloads/publications/Biosimilars_Executive_Summary.pdfRachel Chuhttp://www.stockholm-network.orgnoreply@blogger.com