Biosimilar Drug Development is a Challenging Proposition
Insights from a Bloomberg Panel Discussion
On June 12th, inThought co-hosted a Bloomberg Industries Biosimilars Panel Discussion with Owen Fields, vice president of Worldwide Regulatory Strategy at Pfizer and Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest.
Discussion centered on the commercial viability of biosimilars, focusing on pricing, the increasing influence of payors, and various life cycle management strategies being implemented as barriers to biosimilar adoption.
Panelists also debated key issues of interchangeability, extrapolation, naming, and use of foreign reference data.
The panel discussion continually highlighted the uncertainties and difficulties facing companies seeking to develop biosimilars, whether through the FDA biosimilar pathway or the traditional BLA approval process.
With the requirement for significant upfront investment, uncertain regulations, potential for huge litigation costs, and an uncertain degree of acceptance by physicians and patients, the development of differentiated biosimilars (“biobetters”) may ultimately be the more compelling business model for companies wishing to participate in the biosimilar market.
A more detailed review of the panel discussion can be found here.