The biosimilar insulins are coming

Posted by Scott Kniaz on Wed, Apr 15, 2020

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

March 23, 2020 was a big day for the U.S. insulin market and manufacturers. This day marked the historic completion of the 10-year transition period of certain biologic products, including insulin and human growth hormone, from one regulatory and approval pathway to another. This might sound like nothing more than bureaucratic jargon, but it’s actually very significant, because while insulins have always been biological products, they haven’t always been regulated as such by the FDA. Now that this transition period is over, they will be, increasing competition in a number of different ways. This is all good news for patients, because it’ll drive down prices without, we believe, an impact on innovation.


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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.


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