The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Trends Update — Biosimilars: Sen. Kennedy, Gov. Dean and NVCA Study all Support 12+ Years of Exclusivity

The debate over the proper data exclusivity period for innovator biologics (as protection against biosimilars/follow-on biologics/subsequent-entry biologics) had a busy week last week.

A couple of thoughts:

  1. The exclusivity period in the EU is 8 years (data) +2 years (marketing) +1 year (for new indications), and the current proposal in Canada is 6 years, so a baseline of 12-14 years’ protection would leave the U.S. system paying for exclusive pricing longer than other major markets.  I’m fine if the U.S. decides to further subsidize pharma innovation, but I’d prefer a more transparent approach with less market distortion; and
  2. It’s hard to balance rationally between data exclusivity and patent exclusivity when the patent system is in significant flux.  Having patent reform as a moving piece (or as part of biosimilars legislation) only muddies the debate.

Update: The WSJ picks these up this morning too.  Here’s the NVCA story, and here’s the one on Kennedy’s efforts and the debate it’s generating in committee.

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3 responses to “Trends Update — Biosimilars: Sen. Kennedy, Gov. Dean and NVCA Study all Support 12+ Years of Exclusivity

  1. Pingback: Do the Q2 Venture Capital Numbers plus the HGS Success Indicate a Light at the End of the Tunnel for Biotech Funding? « The Cross-Border Biotech Blog

  2. Pingback: Trends Update — Biosimilars: The State of Play of U.S. Follow-on Biologics Legislation « The Cross-Border Biotech Blog

  3. Pingback: Top Four Biotech Trends of 2009 « The Cross-Border Biotech Blog

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