BIOSIMILARS - Regulatory Framework and Pipeline Analysis – Aarkstore.com

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BIOSIMILARS - Regulatory Framework and Pipeline
Analysis Aarkstore.com
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Summary

• Biosimilars are copied versions of biologics that
  offer a 20-50 reduction in cost compared with
  innovative biologic products. Biosimilars are
  getting the world wide attention as the cost of
  the innovative biologics are enormously high and
  even minimal reduction in price will reduce the
  healthcare spending substantially. All the
  countries are focusing on reducing the healthcare
  expenditure and biosimilars compliments to this
  goal. Biologic products are complex in structure
  and follow a complex manufacturing process thus,
  some variation exists between the reference
  product and its biosimilar. It is very important
  to assess the variations in biosimilars by
  comparing with reference product to ensure
  quality, non-clinical, and clinical properties,
  which has given rise to the regulatory
  requirements for biosimilars. Regulatory
  requirement for approving biosimilars varies
  across different regulatory bodies. However, all
  the countries have derived the basic theme from
  EMA and WHO guidelines for framing their
  regulatory structure. There is a need to
  harmonize the nomenclature of biosimilars,
  extrapolation of indications, and
  interchangeability of biosimilars with reference
  products across the regulatory bodies.
  Biosimilars market is developing and it could be
  well established with the pipeline that is poised
  to deliver a wave of biosimilars in the market in
  the near future

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Table of Content

• Executive Summary Introduction Biosimilars
  Industry Dynamics Trends Drivers Restraints Bi
  osimilars Regulation WHOs Guidance Biosimilars
  in Europe Overview Regulatory Framework Market
  Outlook Biosimilars in the US Overview Regulato
  ry Framework Market Outlook Biosimilars in
  India Overview Regulatory Framework

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List of Tables

• Market Outlook Biosimilars in South
  Korea Overview Regulatory Framework Market
  Outlook Biosimilars in Japan Overview Regulator
  y Framework Market Outlook Biosimilars in
  China Overview Regulatory Framework Market
  Outlook Key Market Players Biosimilars Pipeline
  Analysis Overview By Stage of Development

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List of Figures

•  By Molecule By Therapy Area By Indication By
  MoA/RoA Late-Stage Pipeline Biosimilars Phase
  II Pipeline Biosimilars Phase I Pipeline
  Biosimilars

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