By Sebastien Morisot, Matthew Cook, and Rohit Sood
The growing use of biologics across therapeutic areas, the patent expiration of highly profitable biological products, and increased cost-containment measures make the biosimilar space an attractive development area. The biosimilar market is expected to be worth $25 billion by 2020,1 which drives a growing number of companies to want to get involved (Figures 1A and 1B).
To defend their position against the biosimilar threat, reference-product manufacturers are expected to take significant legal, regulatory, and marketing action. While reference manufacturers can leverage demonstrated real-world, long-term efficacy and safety data as key brand features, it is essential to develop a global, integrated biosimilar defense strategy. Developing a successful biosimilar defense strategy necessitates a careful assessment of the level of risk to the branded product’s business. Risk minimization strategies can then be developed and supported by the deployment of specific tactical tools at the local affiliate level.
Conduct a Risk Assessment
The legal, regulatory, and stakeholder policies surrounding biosimilars vary widely across regions. For a global manufacturer of branded biotechnology products, it is critical to delineate regions according to comparable levels of risk related to price tolerance, access, and uptake. Specifically, branded manufacturers should look to address the following questions to identify country-specific drivers and barriers for biosimilar uptake.