Biosimilars and Originator Biologics 2022 | The Canadian Institute | TBA, Munich

Join us as we track the latest legal and regulatory ramifications for biosimilar stakeholders. Be part of interactive discussions that will enable you to develop a wholistic legal and regulatory strategy for maximizing commercial results for your biosimilar products.

Benefit from in-depth discussions which will allow you to:
• Comprehend how global affairs are transforming the development and commercialization of biologics and biosimilars
• Analyze the global legal and business ramifications of the EMA and FDA biosimilar regulatory pathways
• Understand the significance of regulatory exclusivities in biosimilar development from the perspectives of both originators and biosimilars
• Evaluate the impact of the current SPC landscape and the implementation of the UPC
• Traverse the complexities of U.S. market entry: naming, labeling, and marketing concerns
• Implement winning strategies to prevent compliance breaches of EU competition law
• Learn how AI and data mining accelerate drug discovery and development

2022 Sponsors

ASSOCIATE SPONSORS:
• Dechert LLP
• Patsnap
• Sterne Kessler Goldstein & Fox