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R&D productivity measures consistently under-scored and under-valued, EvaluatePharma data reveals

  • Major biologic approvals worth $4.5bn in 2015 omitted from most FDA approval counts last year
  • Provenge and Prevnar 13 overlooked in majority of 2010 tallies
  • 65 new biologics have largely gone uncounted in the last 12 years
  • Overall picture of declining R&D productivity unchanged
  • Cost of developing new drugs remains unsustainably high

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London, UK – March 14, 2011 – Pharmaceutical R&D productivity is consistently undercounted. Most reports fail to fully count the number of new drugs that reach the market, missing out on billions of dollars of sales generated by R&D investment, an analysis of EvaluatePharma data shows.

Most counts of FDA new drug approvals in 2010 failed to include likely blockbusters Provenge, a prostate cancer treatment, and Prevnar 13, a pneumococcal vaccine, because they were approved by the regulator’s biologics division, CBER. As a greater number of high-value biologicals will be processed by CBER in the future, it is an omission that needs addressing to provide a more accurate reading of R&D productivity.

“With such intense scrutiny of pharmaceutical productivity at the moment, FDA approval rates are an important number to get right,” says Dr Jonathan de Pass, chief executive of EvaluatePharma. “Approvals by CBER are only going to become more important in the future, with advances in areas like gene therapy and the significant investment going into improved haemophilia therapies, for example.”

Including the CBER approved products lifts last year’s tally to 26. Most reports, which only look at the regulator’s CDER division, cited 21 new approvals, underscoring that happens annually, the data shows.

Unfortunately, this upgraded analysis does not improve the overall picture of declining R&D productivity. At the same time, the cost of developing new drugs continues to climb, the data reveals, emphasising the importance of efforts across the industry to improve returns on R&D investment. More...download the full press release