Topics
- Requirements for interchangeability and biosimilarity
- Naming and substitution. Implications and risks
- Current international and local regulation and attempts to reach harmonisation
- Demonstrating biosimilarity in practical terms
- Analysis of the development and commercial factors
- Intellectual property issues
- Current biologics and biosimilars pipeline
- Lessons learned from mature markets
- International regulatory development and approvals
- Main issues behind confidentiality and exchangeability
- Investment opportunities
- Macro analysis and forecast for the biosimilars industry
- Research and development
- State of the art innovation and technologies
- Manufacturing quality and standards
- International partnering and alliances
- Latest trends in biobetters and biosuperiors
- MABs R&D, production and development
- Latest manufacturing technologies and equipment presented through successful case studies
- Latest opportunities and challenges in Latin America
Who should Attend
Representatives from companies and associations related with biologics, biosimilars, biobetters, biotechnology, biotherapeutics.
