Innovators simply cannot afford to ignore biosimilars. These products have the potential to create significant clinical and financial advantages for both patients and payers.
Originator firms must figure out how to integrate the presence of biosimilar products into a therapeutic franchise portfolio strategy — even if the innovator elects not to manufacture a biosimilar. To start, originators must develop a strategy for biosimilar products as part of building and maintaining a therapeutic franchise. This requires defining the portfolio effects of biologically similar therapies on lifecycle management as well as clinical migration. The originator needs to assess three areas:
1. Whether there is a franchise commitment to a therapeutic category
2. Whether presence in that segment is “once and done” with a specific product
3. Determine the appropriate response for the launch of biosimilar agents
Key to building this strategy is a firm understanding of how the clinical, regulatory, and commercial environment for biosimilar products is evolving. Equally important is establishing scenarios that lead to developing follow-on therapies that are clinically and economically differentiated from the originator and the biosimilar products.
Sponsors also should look at partnership opportunities available to bundle a biosimilar with a follow-on innovative therapy. Such bundles may lead to lower prices and entry into new therapeutic categories, giving sponsors the headroom needed to generate new therapies.
All this requires knowledgeable pharmaceutical executives with experience modeling the pathways to secure clinical differentiation, achieving expedited regulatory review, and building sustained value in therapeutic franchise portfolios.
This is an excerpt from Pharm-ers Almanac 2016: The Butterfly Effect. Read the full report here:
About the Author: David Wierz is a YourEncore expert, who regularly consults on commercial strategy for biosimilar products as well as biologics, vaccines and small molecules. He has 25 years of experience working with physician groups, payers and life science companies, including Wyeth (Pfizer), Novartis, Baxalta and Takeda Oncology to name a few.