Biosimilar Interchangeability: Clarity and Ambiguity in the FDA's Final Guidance

Posted by Scott Kniaz on Wed, Jun 19, 2019

Christina Corridon co-wrote this blog post with Scott Kniaz.

Back in April, we wrote a blog post covering almost everything you needed to know about the hot topic of biosimilar interchangeabilitya special designation that allows pharmacies to substitute a biosimilar for a novel biologic product without the input of the prescribing provider. We also told you why it would continue to be in the news for the remainder of 2019—one reason being because the FDA promised to issue finalized guidance on interchangeability by the end of May. Well, that day has come. After releasing its draft guidance more than two years ago, and following a lengthy comment period, the FDA issued the long-awaited document on May 10th. We’ve had a chance to read it and wanted to save you some time by highlighting the most salient issues.


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Biosimilar Interchangeability: What You Need to Know for 2019

Posted by Scott Kniaz on Mon, Apr 01, 2019

Christina Corridon co-wrote this blog post with Scott Kniaz.

In the hallways and boardrooms we occupy, there is a lot of talk of interchangeability of biosimilars right now. Despite all the conversation, there doesn’t seem to be a consensus opinion about its relative value or worthiness. To help you to be more knowledgeable around the watercooler and to help inform your own opinions, let’s start from the beginning, define some key terms, explain what the interchangeability hub-bub is all about, and detail why it is a hot topic that you are hearing more and more about now. 


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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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The Humira Question: Will the Adalimumab Biosimilars Live Up to the Hype?

Posted by Prateek Yadav on Fri, Dec 07, 2018

Prateek Yadav co-wrote this blog post with Christina Corridon, Tucker Herbert, Didier Chicheportiche and Gustavo Poblete.

The biosimilars market in Europe continues to generate buzz as it captures considerable market share from major blockbuster-branded biologics. Most recently, Celltrion's Truxima, a biosimilar of Roche's MabThera (rituximab), captured 32% market share in 18 European countries. Regulatory agencies have also welcomed biosimilars for the promise of the potential cost savings that they bring. Earlier, the U.K.’s National Health Service reported that switching patients from branded drugs to biosimilars and generics led to a savings of £324 million last year.


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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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