Biosimilars - Evolution or Revolution?

A detailed guide to the factors that will shape this vital market, including company strategies, comparability, regulation, the implications for clinical trials and legal issues. With a chapter written by PricewaterhouseCoopers looking at the commercial implications for the biotech and pharmaceutical markets

The market for biotech drugs grew by 18% last year and now exceeds $50 billion – that’s 10% of the global pharmaceutical market at nearly three times the growth rate.

But the first biotech drugs were launched in the mid 1980s and now patents have expired on drugs worth more than $13 billion. Until very recently generic competition was not possible but now in Europe, the EMEA has issued guidelines and the first biosimilar has been approved. In the USA the FDA still has to act, but the direction is becoming clearer. How this market develops will be vital for all the players involved – major pharma, biotechs, generic companies and CROs.

This unique, detailed, 200+ page report, includes a chapter on the commercial implications written by Jo Pisani and Yann Bonduelle, Pharmaceutical & Healthcare strategy consultants at PricewaterhouseCoopers. The report will enable you to:

> See how the biotech landscape will change

> Assess competition in specific markets

> Understand how biosimilars will be approved

> Grasp the details of the trials process

> Understand the legal implications

> Prepare for new launches

Contents include:

> Strategies for entering the market

> The opportunity

> Development

> Profit potential

> Market structure

> Substitution of biosimilars

> Comparability

> The impact of manufacturing

> Preparation of comparability packages

> Immunogenicity risk factors

> Approved biosimilars

> The future

> Clinical trials

> Protocol requirements

> Factors affecting study size

> Regulatory issues Europe

> Clinical trial requirements

> EU guidelines explained

> Dealing with regulators

> Role of the EC

> Case studies and precedents

> Routes to approval

> Regulatory issues USA

> The FDA position

> Anticipated guidance

> Case studies and precedents

> Routes to approval in the US

> Legal issues

> The patent environment

> Freedom to operate

> Precedent

> Opportunities and barriers

> Commercial drivers

> Drug markets

> Country markets

> Skill sets and core competencies

As well as the commercial analysis from PricewaterhouseCoopers the report is edited by Dr Nicole Lyscom and written by leading experts in the field including:

Dr Tim Oldham, VP Business Planning and Operations Effectiveness, Mayne Pharma

Dr Meena Subramanyam, Senior Director, Clinical science and Technology, Biogen Idec

Dr Peter H Kalinka, CEO and Managing Director, Accelsiors Group International

Dr Gabrielle Schaeffner, Principal Consultant, Parexel International, Germany

Dr Alan Liss, Senior Director, Biotechnology, Duramed Research Inc

Dr Antonio Maschino, Partner, D Young and Co

This report is essential reading for anyone in the pharmaceutical, biotech and outsourcing industries from corporate management through development and research to marketing and sales. It gives an authoritative, detailed and clear explanation of the factors that will affect the market for biosimilars and their implications for the market and for the pharmaceutical industry.

Format PDF 2006
Table of Contents
Table of Contents (PDF)
Price: $3,900.00 / GBP1,950.00