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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Biosimilars Adoption: Recognizing and Removing the RoadBlocks.

Sarfaraz K Niazi1

  • 1College of Pharmacy, University of Illinois, Chicago, IL, 60612, USA.

Clinicoeconomics and Outcomes Research : CEOR
|April 20, 2023
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Summary

Biosimilar adoption faces significant roadblocks, including cost, distribution, and perception issues, hindering affordable healthcare access. This analysis identifies these barriers and proposes practical solutions to accelerate biosimilar uptake globally.

Keywords:
EMAFDAMHRAWHOaccessibilityaffordabilitybiosimilaritybiosimilarsdevelopment costregulatory planning

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Area of Science:

  • Pharmaceutical Sciences
  • Health Economics
  • Regulatory Affairs

Background:

  • Biosimilars have been available for nearly two decades but have not achieved widespread adoption as initially expected.
  • Several factors impede broader market penetration, including high costs, distribution challenges, and concerns regarding safety and efficacy.

Purpose of the Study:

  • To analyze the root causes of the slow adoption of biosimilars.
  • To propose practical, actionable solutions to overcome existing barriers.
  • To facilitate the increased availability of affordable biological medicines.

Main Methods:

  • Analysis of current regulatory frameworks and their impact on biosimilar costs.
  • Examination of distribution channels and their inefficiencies.
  • Review of stakeholder perceptions and communication strategies regarding biosimilar safety and efficacy.

Main Results:

  • Identified high amortized cost of goods due to regulatory burden as a key barrier.
  • Highlighted distribution system hurdles and stakeholder focus as significant impediments.
  • Lack of stakeholder alignment on addressing these roadblocks slows progress.

Conclusions:

  • Addressing regulatory burdens and distribution inefficiencies is crucial for biosimilar adoption.
  • Improving stakeholder focus and communication can enhance perception of biosimilar safety and efficacy.
  • Maximizing biosimilar uptake is essential for introducing over 100 new biological molecules to improve global healthcare affordability.