At first glance, it appears that the US market for biosimilars is ready for takeoff In March 2015, the US Food and Drug Administration approved Zarxio from Sandoz, a biosimilar version of Amgen’s blockbuster Neupogen. Four additional biosimilar applications have been filed for FDA review.
For medical technology companies, innovation is a matter of priorities. At least it should be.
Today, however, when its importance is greater than ever, medtech innovation productivity is in decline.
This is not a regulatory issue. The rate of regulatory approval—in terms of 510(k) and other premarket clearances—has been relatively constant since 2011. R&D budgets have been growing by 5% per year. The problem is the declining productivity of medtech companies, which is compounded by the higher burden of proof of efficacy today’s health care systems require. Large multihospital health systems have unprecedented purchasing power; they are putting more price pressure on medtech suppliers and demanding more clinical, operational, and financial benefits of medtech products.