Biogenerics: Drivers and Resistors of Market Development

Table of Contents

CHAPTER 1 KEY FINDINGS

CHAPTER 2 THE REGULATORY ENVIRONMENT FOR BIOGENERICS

Moving toward a regulatory pathway for biogenerics

"Bioequivalence vs. product comparability" and "process makes the product"

Growing demand for biogenerics

US - does the FDA have the right to apply 505(b)(2)?

Europe - is the EMEA a step ahead?

Rest of World - an attractive launchpad?

Implications for biogenerics manufacturers

CHAPTER 3 BIOGENERICS MARKET POTENTIAL

Biogenerics : risk versus return

Drivers of biogenerics market development

Resistors to biogenerics market development

Superbiogenerics

CHAPTER 4 KEY CONTENDERS

Key characteristics for a well positioned biogenerics company

List of Tables

Table 1: Key biological product patent expiries

Table 2: Product classes in the pipelines of 14 biogenerics companies

Table 3: Sales of SICOR's biogenerics portfolio, 2001-02

Table 4: SICOR's biogenerics pipeline, 2003

Table 5: Stada's biogenerics pipeline, 2003

List of Figures

Figure 1: Analysis of classes most at risk from biogeneric competition

Figure 2: Biogenerics capabilities of selected companies

Figure 3: Alliances of selected biogenerics players

Figure 4: BioGeneriX's partnering strategy