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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To Label or Not to Label?

Posted by Sarah Jarvis on Thu, Nov 17, 2016


Sunil John and Jon Gonzales contributed to this post.

To label or not to label? That is the question—or rather, one of the many questions that those invited to the FDA’s much anticipated public forum on off-label communication tried to come to grips with when tackling difficult questions about the topic. 


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Changing the Mindset: Success in Commercializing Rare Disease Drugs

Posted by Michael Thomas on Tue, Apr 26, 2016

There are currently only 314 FDA-approved therapies available among the roughly 7,000 rare diseases that have been identified, according to the Genetic and Rare Diseases Information Center. The global pharmaceutical industry recognizes the unmet need and the opportunity to solve the challenges associated with patients with rare diseases. Current and future pipeline assets offer the pharmaceutical industry an opportunity to bring to market the type of life-changing therapies for patients that add true value where hope is limited.


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