Why You Need to Start Thinking About Meaningful Differentiation Much Earlier

Posted by Emily Mandell on Mon, Jul 01, 2019

Josh Hattem co-wrote this blog post with Emily Mandell.

“That's the problem with the American dream: It makes everyone concerned for the day they're gonna be rich.”

–President Bartlett, The West Wing

Pharma companies may have a winning asset, a winning development plan and an important disease target with unmet needs, but only one product can be first to market, only one can be the most efficacious and only one will become the standard of care. If your asset is entering a disease area with similar efficacy to an established standard of care, or if your asset is one of multiple products in a class entering within one to two years of one another, it’s critical to have a clear understanding of what it will take to meaningfully differentiate, and to do this early enough—in phase I or II—so there's enough time to correct the development plan.


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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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