Safety for Biosimilars: Strategic Pharmacovigilance Solutions

The rapidly expanding landscape of biosimilars presents significant opportunities for increasing patient access to cost-effective alternatives to brand-name biologics, but this also creates unique challenges. Unlike small molecule generics, biosimilars are large, complex molecules with inherent batch-to-batch variability that requires stringent pharmacovigilance across the product lifecycle. To navigate the complexities of biosimilar development and post-market surveillance, it is critical to understand both the evolving regulatory frameworks and the reference products for the biosimilar of interest.

In this webinar, the featured speakers will examine the critical aspects of bringing biosimilars to market and ensuring their ongoing safety and efficacy. They will also explore how pharmaceutical companies can develop effective and scalable pharmacovigilance systems that address the distinct requirements of biosimilar products while maintaining cost-efficiency. Practical solutions for overcoming the most pressing challenges in biosimilar safety management will also be highlighted.

Topics will include:

• Understanding evolving regulations for biosimilar approval, labelling and pharmacovigilance
• Developing pharmacovigilance strategies tailored to biosimilars
• Leveraging advanced technologies and automation to streamline safety surveillance
• Building educational frameworks to support provider and patient adoption

Register for this webinar to learn how strategic pharmacovigilance can improve biosimilar manufacturing and support product adoption.

Speakers

Ivana Lisec, VP, Project Management/Business Unit Leader & EU QPPV, PrimeVigilance

Ivana has 15 years of experience working in PV strategy and operations. Through her exposure to operations, she has helped position companies for future growth and operational optimization, covering pre-, peri- and post-approval settings. Ivana has helped companies establish complex PV systems that have had a proven track record of suitability, agility and compliance. She also acts as EU QPPV. Her strategic leadership skills have been honed through comprehensive scope services and consultative PV programs, encompassing biosimilar and generic portfolios. She holds a Master’s degree in Pharmacy.

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Sara Lipovac, Senior Case Processing Manager, PrimeVigilance

Sara is an experienced pharmacovigilance professional with over five years of increasing responsibility in ICSR management, operational leadership and workflow oversight. She is skilled in leading company-wide implementation of proprietary case intake and management tools and contributing to the development of AI-driven intake capabilities and automation. Sara is also proficient at connecting technical initiatives with operational execution, driving innovation in pharmacovigilance through process improvement and technology-driven efficiency. Lastly, she has demonstrated the ability to lead large teams, manage complex workflows, support regulatory inspections and represent the organization in client engagements.

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