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.
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.
new product launch,