1. Market Research
  2. > Biotechnology
  3. > Biopharmaceutical Market Trends
  4. > BIOSIMILARS - Regulatory Framework and Pipeline Analysis

BIOSIMILARS - Regulatory Framework and Pipeline Analysis

  • June 2015
  • -
  • CBR Pharma Insights
  • -
  • 94 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 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

Table Of Contents

BIOSIMILARS - Regulatory Framework and Pipeline Analysis
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
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
By MoA/RoA
Late-Stage Pipeline Biosimilars
Phase II Pipeline Biosimilars
Phase I Pipeline Biosimilars

View This Report »

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 24 Million searchable statistics with tables, figures & datasets
  • More than 10,000 trusted sources
24/7 Customer Support

Talk to Ahmad

+1 718 618 4302

Purchase Reports From Reputable Market Research Publishers
Remicade Biosimilar Market: By Type (Recombinant Non-Glycosylated Protein, Others), By Technology (MAb, rDNA, Others), By Service (Contract Research, CRAMS,Others), By Application (Blood Disorders, Oncology Diseases, Others), By Region-Forecast (2016-2021

Remicade Biosimilar Market: By Type (Recombinant Non-Glycosylated Protein, Others), By Technology (MAb, rDNA, Others), By Service (Contract Research, CRAMS,Others), By Application (Blood Disorders, Oncology Diseases, Others), By Region-Forecast (2016-2021

  • $ 5250
  • Industry report
  • September 2016
  • by Industry ARC

Globally, development of efficient and advance technology, higher expiration patent, rise in the awareness among people regarding remicade biosimilar, increasing government initiative across the globe, ...

Biosimilar - Global Market Outlook (2016-2022)

Biosimilar - Global Market Outlook (2016-2022)

  • $ 4157
  • Industry report
  • September 2016
  • by Stratistics MRC

According to Stratistics MRC, the Global Biosimilars market is estimated to be $3.5 billion in 2015 with a CAGR of 23.8% is poised to reach $15.6 billion by 2022. High end adoption of off patented drugs ...

Insulin Biosimilars - Global Market Outlook (2016-2022)

Insulin Biosimilars - Global Market Outlook (2016-2022)

  • $ 4157
  • Industry report
  • October 2016
  • by Stratistics MRC

According to Stratistics MRC, the Global Insulin Biosimilars market is accounted for $xx million in 2015 and is expected to reach $xx million by 2022 growing at a CAGR of xx% from 2015 to 2022. Growing ...


ref:plp2015

Reportlinker.com © Copyright 2016. All rights reserved.

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