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 After releasing its draft guidance more than two years ago, and following a lengthy comment period, the FDA issued the long-awaited document on May 10th.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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Now I Know What It Means to Be a Rock Star

Posted by Michael Thomas on Wed, Jun 12, 2019

The lights go down. The crowd erupts in anticipation. An iconic rock band is about to step on stage, and you are about to take part in an immersive, overwhelming experience for the next three hours. I love this moment, and I’ve always wondered what it must be like on that stage, knowing that people are so inspired by what I do. 


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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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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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