BIOSIMILARS - Regulatory Framework and Pipeline Analysis: Radiant Insights
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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
For more details about this report, click here: http://www.radiantinsights.com/research/biosimilars-regulatory-framework-and-pipeline-analysis
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
For more reports of this category by Radiant Insights, Visit here: http://www.radiantinsights.com/catalog/pharmaceuticals-and-healthcare
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
About Radiant Insights
Radiant Insights is a platform for companies looking to meet their market research and business intelligence requirements. It assist and facilitate organizations and individuals procure market research reports, helping them in the decision making process. The Organization has a comprehensive collection of reports, covering over 40 key industries and a host of micro markets. In addition to over extensive database of reports, 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/
Media Contact:
Company Name: Radiant Insights, Inc
Contact Person: Michelle Thoras
Email: sales@radiantinsights.com
Phone: (415) 349-0054
Address: 28 2nd Street, Suite 3036
City: San Francisco
State: California
Country: United States
Blog: http://rimarketresearchandreports.blogspot.in/
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
For more details about this report, click here: http://www.radiantinsights.com/research/biosimilars-regulatory-framework-and-pipeline-analysis
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
For more reports of this category by Radiant Insights, Visit here: http://www.radiantinsights.com/catalog/pharmaceuticals-and-healthcare
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
About Radiant Insights
Radiant Insights is a platform for companies looking to meet their market research and business intelligence requirements. It assist and facilitate organizations and individuals procure market research reports, helping them in the decision making process. The Organization has a comprehensive collection of reports, covering over 40 key industries and a host of micro markets. In addition to over extensive database of reports, 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/
Media Contact:
Company Name: Radiant Insights, Inc
Contact Person: Michelle Thoras
Email: sales@radiantinsights.com
Phone: (415) 349-0054
Address: 28 2nd Street, Suite 3036
City: San Francisco
State: California
Country: United States
Blog: http://rimarketresearchandreports.blogspot.in/