US biosimilars approvals expected to increase despite challenges

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Biosimilar approvals in the US are expected to increase during the next five years, despite safety and regulatory challenges, according to a study from the Boston-based Tufts Center for the Study of Drug Development (CSDD).

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Things that could hinder market uptake of biosimilars include safety concerns among physicians and the need for greater regulatory clarity concerning therapeutic interchangeability.

Joshua Cohen, Associate Professor at Tufts CSDD and author of the study, expects ‘payers in the US will encourage biosimilar prescribing by offering lower patient cost-sharing for biosimilars, compared to originator biologicals’.

Other findings from the analysis, reported in the March/April Tufts CSDD Impact Report, published on 5 March 2015, include:

  • Development costs for a biosimilar are substantially less than similar costs for originator biologicals, but creating biosimilars is more challenging than developing small-molecule generics due, in part, to greater chemical complexity of biologicals and a more demanding manufacturing process
  • Over the next 10 years, biosimilars could save more than US$40 billion in worldwide biologicals spending, as biosimilar pricing is expected to be 15% to 35% less than originator biologicals pricing
  • Approximately two-thirds of US physician opinion leaders surveyed by Tufts CSDD said they would likely prescribe biosimilars to new patients, with about one-third saying they would be unlikely to switch an existing patient from an originator biological to a biosimilar

The news of the US Food and Drug Administration’s approval of Sandoz’s filgrastim biosimilar (Zarxio) on 6 March 2015 [1] adds weight to the study’s findings that biosimilar approvals will increase.

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1.   GaBI Online - Generics and Biosimilars Initiative. ‘FDA approves its first biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 27]. Available from: 

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Source: Tufts

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