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BIOSIMILARS - Regulatory Framework and Pipeline Analysis – Aarkstore.com

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Title: BIOSIMILARS - Regulatory Framework and Pipeline Analysis – Aarkstore.com


1
BIOSIMILARS - Regulatory Framework and Pipeline
Analysis Aarkstore.com
2
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

3
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

4
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

5
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

Browse full report Or Sample Request
_at_ http//www.aarkstore.com/pharmaceuticals-health
care/126161/biosimilars-regulatory-framework-and-p
ipeline-analysis
6
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7
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ise
8
Contact Us
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