Overcoming hurdles to biosimilars cost savings in the US

Biosimilars/Research | Posted 14/08/2015 post-comment0 Post your comment

The US approved its first biosimilar, Zarxio (filgrastim-sndz), on 6 March 2015 [1]. But how can the country overcome hurdles to the cost savings that can be achieved from these drugs? That is a question Sarpatwari and co-authors have tried to answer [2]. 

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The authors believe that the challenges to achieving savings from biosimilars ‘are large but not insurmountable’. They outline the following ways to ensure that potential savings from biosimilars are achieved in the US:

  • Market-entry hurdles should be low enough to ensure that enough companies compete to affect prices
  • Public investment in technological advances that can support biosimilar development, such as advancing knowledge about glycosylating human proteins in yeast
  • FDA should produce product-specific guidance on how companies can demonstrate biosimilarity or interchangeability, to reduce the disadvantages for the first companies to try
  • Prevent unreasonable delay in patent-infringement cases by re-examining process
  • Prevent anti-competitive settlements by re-examining the process for exchanging information about potentially infringing patents
  • Extend requirement for settlements to be reported to the Federal Trade Commission to cover biologicals

The authors conclude that ‘innovative approaches will be required to ensure mandatory, rigorous post-approval research on the safety and effectiveness of biosimilars compared with their innovator predecessors in order to promote confidence in these new products.’ This will result in US patients reaping the benefits of potential cost reductions from biosimilars.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar
2. Sarpatwari A, Avorn J, Kesselheim AS. Progress and hurdles for follow-on biologics. N Engl J Med. 2015 May 6. doi:10.1056/NEJMp1504672

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