Biosimilars Regulatory Framework And Pipeline Analysis – Aarkstore.Com

752 words - 4 pages

BIOSIMILARS - Regulatory Framework and Pipeline Analysis

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 ...view middle of the document...

- 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
Table Of Content
Executive Summary
Introduction
Biosimilars Industry Dynamics
Trends
Drivers
Restraints
Biosimilars Regulation: Whos Guidance
Biosimilars In Europe
Overview
Regulatory Framework
Market Outlook
Biosimilars In The Us
Overview
Regulatory Framework
Market Outlook
Biosimilars In India
Overview
Regulatory Framework
...

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