A strong regulatory strategy starts with a solid understanding of all regulatory pathways and support mechanisms to ensure an efficient entry to market. Whether you are in the brand, biosimilar, or generic space, it is particularly important to understand how biosimilar and generic competitors design their path to market and lifecycle management strategies. Key to any robust regulatory strategy isidentification of risks and opportunities to your product. The session showcases why understanding biosimilar and generic (Competitive Generic Therapy designation (“CGT”), complex generics, 505(b)(2)) drug development approach and the potential timelines for competitor entry are a strategic imperative to minimize time and cost while maximizing market potential of a brand, biosimilar and generic drug candidate.
Describe the various pathways by which a biosimilar and generic may come to market.
Identify which factors play a role in designing a strong regulatory strategy for market entry and lifecycle management.
Incorporate strategic thinking into how current trends in pharmaceutical industry may influence the regulatory strategy.