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. 


>
Read More

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.


>
Read More

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.


>
Read More

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.


>
Read More

Decoding How Stakeholders Drive Biosimilar Adoption

Posted by Tucker Herbert on Thu, Mar 15, 2018

Disparate uptake of biosimilars to date show that developing a biosimilar is far from a sure bet. Launching any new drug is challenging, but launching a biosimilar can be especially tricky because of the increased uncertainty across regulatory, legal and commercial spheres on one hand and an expectation that significant promotional effort will be required (without being able to differentiate on safety/efficacy) on the other. Is choosing between biosimilars (or an originator) making a therapeutic choice? In the eyes of the FDA, unless a biosimilar has been granted interchangeability, the product choice remains with MDs as the products have been deemed to have equivalent safety/efficacy without being identical. (Other key stakeholders are developing a range of perspectives on this topic.) To ensure commercial success, biosimilar developers (and defenders) need to have a strategic plan for forecasting and conducting market research to fully understand the market complexity. It’s also critical to align the incentives for providers, patients, payers, pharmacists and procurement—all of whom can play a critical role in driving or delaying a new biosimilar’s uptake.


>
Read More