Putting Agile Launch Into Practice

Posted by Ben Hohn on Wed, Mar 27, 2019

Judith Kulich, Mike Kelly, Christina Corridon, Mary Ann Godwin and Kapila Viges co-wrote this blog post with Ben Hohn.

Most large pharma and biotechnology companies have historically relied on a singular "best practice model" for preparing for launch. Highly structured and rigid launch readiness models made sense in a world where similarities between launches were significant. As pipelines and portfolios have evolved dramatically—now reflecting launches in specialty, rare disease, combination therapies, personalized medicine, and follow-on indications instead of mass-market blockbusters—a rigid, one-size-fits-all model for launch excellence isn’t sufficiently relevant for each launch. A new launch excellence model that’s more agile, flexible and reflective of the varied launches that a company faces should be the goal.


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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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