1. Market Research
  2. > Biotechnology
  3. > Biopharmaceutical Market Trends

BIOSIMILARS - Regulatory Framework and Pipeline Analysis

  • June 2015
  • 94 pages
  • CBR Pharma Insights
Report ID: 3087009

Summary

Table of Contents

Search Inside

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 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

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

Reasons to buy

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

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 60 Million searchable statistics with tables, figures & datasets
  • More than 25,000 trusted sources
  • Single User License — provides access to the report by one individual.
  • Department License — allows you to share the report with up to 5 users
  • Site License — allows the report to be shared amongst all employees in a defined country
  • Corporate License — allows for complete access, globally.

Veronica helps you find the right report:

Testimonials

The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

We were impressed with the support that ReportLinker’s research specialists’ team provided. The report we purchased was useful and provided exactly what we want.

Category Manager at
Ikea

ReportLinker gave access to reliable and useful data while avoiding dispersing resources and spending too much time on unnecessary research.

Executive Director at
PwC Advisory

The customer service was fast, responsive, and 100% professional in all my dealings (...) If we have more research needs, I'll certainly prioritize working with ReportLinker!

Scott Griffith

Vice President Marketing at
Maurice Sporting Goods

The research specialist provided prompt, helpful instructions for accessing ReportLinker's product. He also followed up to make sure everything went smoothly and to ensure an easy transition to the next stage of my research

Jessica P Huffman

Research Associate at
American Transportation Research Institute

Excellent customer service. Very responsive and fast.

Director, Corporate Strategy at
Ingredion

I reached out to ReportLinker for a detailed market study on the Air Treatment industry. The quality of the report, the research specialist’s willingness to solve my queries exceeded my expectations. I would definitely recommend ReportLinker for in-depth industry information.

Mariana Mendoza

Global Platform Senior Manager at
Whirlpool Corporation

Thanks! I like what you've provided and will certainly come back if I need to do further research works.

Bee Hin Png

CEO at
LDR Pte Ltd

The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

Purchase Reports From Reputable Market Research Publishers

OpportunityAnalyzer: Growth Hormone Deficiency - Opportunity Analysis and Forecasts to 2026

  • $ 10995
  • Industry report
  • May 2017
  • by GlobalData

OpportunityAnalyzer: Growth Hormone Deficiency - Opportunity Analysis and Forecasts to 2026 Summary Growth hormone deficiency (GHD) is a rare endocrine disorder characterized by inadequate secretion of ...

Erythropoietin (EPO) Drugs Market Analysis By Drug Class (Biologics, Biosimilars), By Product (Epoetin-alfa, Epoetin-beta, Darbepoetin-alfa, Others), By Application, And Segment Forecasts, 2014 - 2025

  • $ 4950
  • Industry report
  • May 2017
  • by Grand View Research

The global erythropoietin (EPO) drugs market is expected to reach USD 17.4 billion by 2025, according to a new report by Grand View Research, Inc. Rising incidence of chronic diseases such as CKD and cance ...

Global Biosimilars Market

  • $ 4250
  • Industry report
  • July 2017
  • by Mordor Intelligence LLP

The global biosimilar market was estimated to be USD XX million in 2016 and is expected to reach USD XX million by 2021, witnessing a CAGR of XX% during the forecast period. Biosimilar is a biological ...


ref:plp2015

Reportlinker.com © Copyright 2017. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.