The Cross-Border Biotech Blog

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

FTC Weighs In: Favors Compromise on Biosimilars Exclusivity, Disfavors Pay-For-Delay

The FTC released a report today that explores the economics of biosimilars’ market entry and competition.  It predicts that biosimilars will be priced only 10 to 30% under their corresponding pioneer biologics; and that pioneer biologics will retain 70-90% of their market share subsequent to biosimilar market entry. 

Based on these predictions, the FTC concludes that the proposed 12-14 year exclusivity period (here’s looking at you, Eshoo-Barton) is “too long.”  I’m sticking with my guess that we see a compromise from Waxman on the exclusivity period, landing around 8-10 years.

The report also reiterates the FTC’s opposition to pay-for-delay deals and corresponding support for H.R. 1706.

P.S. The InVivo blog says there’s convergence on “biosimilars” over  “generic biologics” and “follow-on biologics” as the nomenclature of choice (presumably “subsequent-entry biologics” loses too), so I’m running with it.

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4 responses to “FTC Weighs In: Favors Compromise on Biosimilars Exclusivity, Disfavors Pay-For-Delay

  1. Mike Foorer June 11, 2009 at 9:59 am

    Great post! I think Canada has it right with “Subsequent entry biologics”

    • Jeremy G June 11, 2009 at 9:32 pm

      Thanks Mike! I’m curious — are you cheering for the Canadian nomenclature or the policy?

  2. Pingback: Trends Update — Biosimilars: Obama Administration Supports 7-Year Exclusivity Period « The Cross-Border Biotech Blog

  3. Pingback: Trends Update — Biosimilars: Sen. Kennedy, Gov. Dean and NVCA Study all Support 12+ Years of Exclusivity « The Cross-Border Biotech Blog

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