Safety for Biosimilars: Strategic Pharmacovigilance Solutions

The global biosimilars market is rapidly expanding, creating new opportunities to improve patient access to cost-effective alternatives to brand-name biologics. However, these large and complex molecules also introduce unique safety and regulatory challenges that demand a specialized pharmacovigilance (PV) approach.

Unlike small molecule generics, biosimilars exhibit inherent variability due to their biological nature and manufacturing sensitivity. Maintaining their safety and efficacy throughout the product lifecycle requires robust PV systems that can anticipate, detect, and manage risks efficiently—while ensuring regulatory compliance and public confidence.

In this webinar, PrimeVigilance experts Ivana Lisec and Sara Lipovac will share their insights into how strategic, scalable pharmacovigilance systems can support biosimilar development and long-term safety management. The discussion will explore evolving regulatory expectations, the role of automation and AI in safety surveillance, and best practices for ensuring patient and provider trust in biosimilar adoption.

 

Key Discussion Topics:

• Why biosimilars require dedicated pharmacovigilance strategies distinct from traditional generics
• How automation and AI can enhance safety data management and reporting efficiency
• Evolving global regulations for biosimilar approval and post-market safety monitoring
• Practical considerations for operationalizing PV systems across global programs
• Best practices for education and engagement to foster healthcare provider and patient confidence

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