Biosimilars regulatory framework and pipeline analysis

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BIOSIMILARS - Regulatory Framework and Pipeline Analysis: Radiant Insights 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

To Download Sample Copy of This Report, Visit here: http://www.radiantinsights.com/research/biosimilars-regulatory-framework-and-pipelineanalysis Scope 

The scope of the report includes - Introduction - Market dynamics: Trends, Drivers, and Barriers - WHO guidance for biosimilars - Regulatory overview, biosimilar guidelines, regulatory framework for biosimilars, and market outlook for: Europe, USA, India, South Korea, Japan and China. - Key players - Pipeline Analysis - Overview - By Stage of Development / Molecule / Therapy Area / Indication - Late-Stage / Phase II / Phase I Pipeline Biosimilars


Key Reasons to Purchase 

The report will enhance your decision-making capability by allowing you to - Understand the regulatory requirement and regulatory framework that facilitates effective product development strategy as biosimilars industry is currently highly focused, growing, and outpacing the growth rate of small molecule pharmaceutical market - Targeting geographies would be easy by comparing different regulatory frameworks; this would also provide a base for designing a strategy to enter the developed markets. Biosimilars are of interest in developed countries to reduce the healthcare expenditure - With the recent approvals of biosimilars by USFDA, the biosimilars market is going to grow and this report examines the post approval market landscape - Examine the biosimilars pipeline and specifies the products that are highly targeted, it also includes analysis of highly focused indications, mechanism of actions, and therapy areas in the pipeline - Analyze the details of the clinical pipeline that includes late stage products, Phase II, and Phase I products. Detailed understanding of the pipeline will help in targeting the products for development, rate the current products and predict the competition

To Download Sample Copy of This Report, Visit here: http://www.radiantinsights.com/research/biosimilars-regulatory-framework-and-pipelineanalysis Table Of Content Executive Summary Introduction Biosimilars Industry Dynamics Trends Drivers Restraints Biosimilars Regulation: WHO's Guidance Biosimilars in Europe Overview


Regulatory Framework Market Outlook Biosimilars in the US Overview Regulatory Framework Market Outlook Biosimilars in India To Download Sample Copy of This Report, Visit here: http://www.radiantinsights.com/research/biosimilars-regulatory-framework-and-pipelineanalysis Overview Regulatory Framework Market Outlook Biosimilars in South Korea Overview Regulatory Framework Market Outlook Biosimilars in Japan Overview Regulatory Framework Market Outlook Biosimilars in China Overview Regulatory Framework


Market Outlook Key Market Players Biosimilars Pipeline Analysis Overview By Stage of Development By Molecule By Therapy Area By Indication To Download Sample Copy of This Report, Visit here: http://www.radiantinsights.com/research/biosimilars-regulatory-framework-and-pipelineanalysis By MoA/RoA Late-Stage Pipeline Biosimilars Phase II Pipeline Biosimilars Phase I Pipeline Biosimilars About Radiant Insights Radiant Insights is a platform for companies looking to meet their market research and business intelligence requirements. We assist and facilitate organizations and individuals procure market research reports, helping them in the decision making process. We have a comprehensive collection of reports, covering over 40 key industries and a host of micro markets. In addition to over extensive database of reports, our experienced research coordinators also offer a host of ancillary services such as, research partnerships/ tie-ups and customized research solutions. For More Information, Visit http://www.radiantinsights.com/ Contact: Michelle Thoras Corporate Sales Specialist, USA


Radiant Insights, Inc Phone: 1-415-349-0054 Toll Free: 1-888-202-9519 Email: sales@radiantinsights.com Company: Radiant Insights Blog: http://rimarketresearchandreports.blogspot.in/


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