The Future of Biosimilars: Key opportunities & emerging therapies

Table of Contents

• Introduction to biosimilars
• Market landscape for biosimilars: Europe and USA
• Emerging market landscape for biosimilars: China and India
• Competitive landscape
• Case studies
• Future trends in biosimilars

• Summary
• Introduction
• Biosimilars vs generic pharmaceuticals
• The nomenclature debate
• Market opportunities
• Key trends in biosimilar product development
• Industry profile
• Challenges faced by biosimilar developers
• Pre-marketing hurdles
• Post-marketing challenges
• Future trends

• Summary
• Introduction
• Features of the EU market for biosimilars
• Regulatory framework
  • Experience with EU framework
  • National laws
• Drivers and constraints for biosimilars in the EU market
• Features of the US market for biosimilars
• Regulatory framework
  • Follow-on biotech drugs
  • Follow-on biologicals
• Experience with US regulatory mechanisms
• Drivers and constraints for biosimilars in the US market

• Summary
• Introduction
• Features of the Chinese market for biosimilars
• Regulatory framework
• Biopharmaceutical market
• Biopharmaceutical industry
• Features of the Indian market for biosimilars
• Regulatory framework
• Biopharmaceutical industry
• Conclusion

• Summary
• Introduction
• Leading biosimilars players
• Teva
• Sandoz
• Barr/Pliva
• Biopartners/Bioton
• Stada/Bioceuticals
• BioGeneriX/ratiopharm
• Niche players
• CoGenesys
• Maxygen
• Viropro
• Trends in the biosimilars industry

• Summary
• Introduction
• Sandoz' Omnitrope: a regulatory saga
• Comparison of EU approval routes for Omnitrope and Valtropin
• Conclusions
• Targeting superbiosimilars: Neose Technologies
• EPO market
• G-CSF market
• Conclusions
• Taking developed products to market: SciGen
• Manufacturing risks
• Marketing strategy
• Pipeline growth
• Conclusions

• Summary
• Introduction
• Main product opportunities
• Product development issues
• Pricing trends
• Market impact of biosimilars
• Factors affecting biosimilar penetration
  • Interchangeability/substitution policies
  • Product differentiation
  • Marketing strategies
  • Competition

• Primary research methodology
• Glossary
• Index

• Figure 1.1: Product groups most affected by biosimilars by 2010
• Figure 1.2: Major challenges faced by biosimilar companies
• Figure 3.3: Markets with highest potential for biosimilar penetration
• Figure 3.4: Development of Chinese biopharmaceutical market, 2001-2006
• Figure 4.5: Types of partnerships favored by biosimilar companies
• Figure 5.6: Global EPO market
• Figure 5.7: Global G-CSF market
• Figure 6.8: Price differential between original brand and biosimilar
• Figure 6.9: Penetration of biosimilars in biotech market by 2010

• Table 1.1: Sales trends of leading biologics by product category, 2006
• Table 1.2: Patent status of key categories
• Table 1.3: Marketed biosimilars by product group
• Table 1.4: Summary of leading companies' biosimilar projects
• Table 4.5: Teva' s biosimilar products
• Table 4.6: Stada' s geographical sales distribution
• Table 6.7: Selected target products for biosimilar developers