2016 - Biosimilars Cusp of a New Era Market Research Review Report

Hexa Reports
Market Research Reports and Insightful Company Profiles

BIOSIMILARS cusp of a new era Market Share, Size,
Trends, Growth, Analysis and Outlook Research
Report by Hexa Reports

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
Browse Detail Report With TOC @ http://www.hexareports.com/report/biosimilars-regulatoryframework-and-pipeline-analysis/details
The scope of the report includes - Introduction
- Market dynamics: Trends, Drivers, and Barriers

Hexa Reports
Market Research Reports and Insightful Company Profiles
- WHO guidance for biosimilars
- Regulatory overview, biosimilar guidelines,...