Even in a Favorable Regulatory Environment, Will Biosimilars Gain Traction in the US This Year?

Posted by Pratap Khedkar on Fri, Jan 25, 2019

Christina Corridon co-wrote this blog post with Pratap Khedkar.

Despite 16 approvals in the last four years, just six biosimilars currently are being marketed stateside. The U.S. biosimilars market hasn’t progressed as anticipated, yet some experts are wondering whether the biologic follow-ons can redeem themselves with a breakout year in 2019.

The U.S. biosimilars market has a tough road ahead. The WAC list price differential between biosimilars and the originator drugs is hovering around 30%, on average, which likely isn’t speeding biosimilars’ adoption in the U.S. Rather than playing the long game and waiting for the U.S. landscape to become more attractive, some biosimilar manufacturers like Momenta are choosing to exit the market. And others like Pfizer have shuttered their preclinical biosimilar programs to focus their efforts elsewhere. On the flip side, the Trump administration has zeroed in on drug pricing and biosimilars as priorities—and, of course, the two are intertwined.


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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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