Strategies for Entering the Biosimilars Market

2012-01-06
Published : Jan-2012

Report Summary

The challenges and opportunities presented by the evolving biosimilars market in the regulated markets of the EU, US, and Japan, and the emerging markets of Brazil, Russia, India, China, and Korea are examined. Strategies employed by a diverse range of companies to enter the biosimilars market enable conclusions to be drawn on key factors for success in this sector.

Features and benefits

* Appreciate the regulatory, clinical, and commercial expertise required to participate in the biosimilars market segment.
* Identify the main competitors in the biosimilars industry and gain insight into their differing biosimilar strategies.
* Assess the benefits of partnerships and alliances in gaining market entry.
* Identify key market and product opportunities, and evaluate regulatory hurdles.
* Gain an insight into the main drivers of future market development.

Strategies for Entering the Biosimilars Market

Published: December 2011
No.OF Pages: 115
Price: Single User License – US$ 3835      Corporate User License US$ 14381

Table Of Contents

About the author
Disclaimer

EXECUTIVE SUMMARY
Overview of the biosimilars market
Strategic considerations for biosimilar market entry
Generics industry biosimilar strategies
Research-based industry biosimilar strategies
Role of contract service providers
Identifying biosimilar opportunities

Overview of the biosimilars market
Summary
Introduction
Definitions
Target molecules
Main players
Markets
Developed markets
Emerging markets
Opportunities and challenges

Strategic considerations for biosimilar market entry
Summary
Introduction
Regulatory environment
EU biosimilars guidelines
Japan’s guidelines
US abbreviated pathway
Canada’s SEB guidance
Australia
Emerging markets
South Korea
China
India
Intellectual property
Biosimilar-specific patent environment
US perspective
Product development
Clinical data
Immunogenicity
Pharmacovigilance
Commercialization
Pricing structures

Generics industry biosimilar strategies
Summary
Introduction
Global players
Sandoz
Hospira
Teva
Regional players
Case study: Biocon (India)
Case study: Dr Reddy’s
Case study: Gedeon Richter (Hungary)

Research-based industry biosimilar strategies
Summary
Introduction
Bayer HealthCare Pharmaceuticals
GlaxoSmithKline
Merck BioVentures
GlycoFi
Biosimilars pipeline
Partnership with Parexel
Manufacturing agreement with MedImmune
Pfizer
Other multinationals following suit
Biotech companies

Role of contract service providers
Summary
Introduction
Strategic alliances
Lonza-Teva joint venture
Celltrion
Parexel-Merck partnership
Quintiles-Samsung partnership
Supply and demand

Identifying biosimilar opportunities
Summary
Introduction
Market opportunities
Developed markets
Emerging markets
Product opportunities
EPO
G-CSF
Insulin
Cancer antibodies
Anti-TNF antibodies

Best practices for biosimilar market entry
Summary
Introduction
Key capability requirements
Product selection
Regulatory expertise
CMC
Clinical development
Successful commercialization

Appendix
Methodology
References
Abbreviations

List Of Tables

Table: Top 10 biologicals sales and patent expiries
Table: EU approved biosimilars
Table: EU biosimilar guidelines
Table: Clinical development of two different biosimilar filgrastims
Table: Hospira’s biosimilar-related acquisitions and alliances
Table: Hospira biosimilars pipeline (June 2011)
Table: Teva’s biosimilars-related acquisitions and alliances
Table: Summary of big pharma biosimilar partnerships and acquisitions
Table: Celltrion’s biosimilars pipeline
Table: Biocad’s pipeline of biologicals
Table: Leading biological product classes

List Of Figures

Figure: Main biosimilar players
Figure: Examples of partnerships providing entry to the biosimilars market
Figure: Global biosimilar sales ($m), 2010
Figure: Timeline for development of a biosimilar medicine
Figure: Manufacturing processes for recombinant proteins
Figure: Biosimilar quality-by-design process
Figure: Biologics market by region ($m), 2010 and 2016

 

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