What It’ll Take to Follow in Gottlieb’s Footsteps: Protect, Innovate and Scale

Posted by Pratap Khedkar on Thu, Mar 21, 2019

Matt Furlow co-wrote this blog post with Pratap Khedkar.

Scott Gottlieb’s nearly two-year stint as commissioner of the FDA is coming to an end, and with the ink on his resignation letter barely dry, Norman Sharpless was appointed acting head. Gottlieb is a tough act for the former director of the National Cancer Institute to follow, even temporarily. Gottlieb brought welcome change to the agency and excelled across three ideal FDA leader focus areas—to protect, innovate and scale up—when historically, the agency’s focus had been heavily skewed to protect, was slow to innovate and was cautious to scale up.


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Can the FDA’s Biosimilars Action Plan Change the Game for Biosimilars in the U.S.?

Posted by Tucker Herbert on Wed, Oct 17, 2018

Vartika Pandya and Ross Shahinian co-wrote this blog post with Tucker Herbert.

To address healthcare system costs, the Biologics Price Competition and Innovation Act established an abbreviated pathway for less expensive copies of biologic drugs called biosimilars. Biosimilars have struggled to penetrate the U.S. market, including those developed by major players. Biosimilars of Remicade (infliximab) have managed to capture only 6% of the U.S. market 21 months post-launch. By contrast, the EU has witnessed a more rapid uptake of biosimilars, likely due to stronger payer control and regulatory guidelines facilitating biosimilar penetration (such as the NHS commissioning framework for biological medicines in the U.K.). In the U.S., the FDA has followed suit by developing the Biosimilars Action Plan (BAP) to strike a balance between innovation and competition in the U.S. biologics market.


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