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Biosimilars – Regulatory Framework and Pipeline Analysis

Published: Jun-2015 | Format: PDF | CBR Pharma Insights | Code: MRS - 18104


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


  • 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

  • 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

Executive Summary


Biosimilars Industry Dynamics




Biosimilars Regulation: WHO's Guidance

Biosimilars in Europe


Regulatory Framework

Market Outlook

Biosimilars in the US


Regulatory Framework

Market Outlook

Biosimilars in India


Regulatory Framework

Market Outlook

Biosimilars in South Korea


Regulatory Framework

Market Outlook

Biosimilars in Japan


Regulatory Framework

Market Outlook

Biosimilars in China


Regulatory Framework

Market Outlook

Key Market Players

Biosimilars Pipeline Analysis


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

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