Bloomberg's Big Gulp on Biosimilalrs

  • by: |
  • 06/20/2012
The channel -- not the mayor.

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.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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