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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Ramping Up Real-World Evidence: Assessing the FDA’s New RWE Framework

Posted by Qin Ye on Thu, Jan 24, 2019

Ishita Srivastava and Divya Babbar co-authored this blog post with Qin Ye.

The FDA considers the use of real-world data and real-world evidence a top strategic priority, and on Dec. 6, it unveiled its much-anticipated RWE framework to support the development of drugs and biologics. The framework is aimed at evaluating the potential use of RWE for assessing a product’s effectiveness and focuses on increased stakeholder engagement to effectively leverage RWD and RWE for public health purposes.


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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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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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