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Biologics, biosimilars, and interchangeable biologics: US update after first launch

Related topics: Pharmaceutical/Biotech, USA, Market Access & HEOR, Biosimilars

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  • The US is essentially a “secondary” market for biosimilars; as such, what can be learned from other markets?
  • The business model for biosimilars, neither branded or generic products, is likely to be different in the US than in other markets, especially when it comes to pricing. How will business models be structured and operate?
  • With only 5 applications and 1 approval to date, there isn’t yet a clear regulatory pathway for biosimilars in the US. What might that pathway look like when more fully developed?
  • With originators of branded products making more defensive manoeuvres in the US than in other countries, lifecycle management of biosimilars is likely to be different in the US than elsewhere. What differences will there be?

Kathleen E. Hughes
Vice President, Avalere Health, USA


This is the presenters’ personal opinion and does not necessarily represent true facts, the official views or policy of their organisation, nor the views of Evidence Life Science.