Five Strategic Imperatives for Biosimilar Pharmacovigilance Leaders

As biosimilars gain market traction globally, pharmacovigilance (PV) professionals are being tasked with managing a complex class of therapies. Unlike small-molecule generics, biosimilars are large, living-cell-derived biologics that require meticulous validation to confirm safety, efficacy, and regulatory compliance.

The opportunity is compelling: the global biosimilars market is projected to surpass $150 billion by 2033, growing at a compound annual growth rate of 18 percent.[i]^,[ii] However, with growth comes complexity, rising regulatory expectations, evolving patient preferences, and pressure to deliver results under tight financial constraints.

To succeed now and into the future, PV leaders must rethink legacy systems and adopt tailored, technology-enabled strategies. Based on the latest research and best practices, this article outlines five strategic imperatives for managing the biosimilar pharmacovigilance landscape.

 

 

1. Customize Safety Surveillance to Biosimilar Biology

Biosimilars are not interchangeable at the molecular level with their reference products. Minor manufacturing variances can affect immunogenicity and therapeutic outcomes.[i] Standard PV protocols are insufficient.

Imperatives for PV teams:

• Develop molecule-specific post-marketing surveillance plans.
• Implement lot-level traceability for accurate tracking of adverse events.³
• Integrate device use data, especially for auto-injectors and pen dispensers.

These activities demand cross-functional coordination between safety, manufacturing, and quality functions³,including robust medical information setting. The complexity is amplified by the growing trend of using biosimilars in combination with digital health tools and remote monitoring devices, increasing the data ecosystem that PV must oversee.[ii]

 

2. Close the Real-World Data Gap with Smarter Traceability Systems

Traditional traceability methods are inadequate in real-world, self-administered settings. Without accurate lot-level data, signal detection and aggregate safety analysis lack reliability.

Actionable strategies:

• Introduce barcode scanning and digital lot tracking apps for patients and caregivers.
• Partner with patient support programs (PSP) and specialty pharmacies to streamline data capture.
• Standardize data collection to include packaging configuration and delivery mechanisms.

Global health authorities are pushing for stronger real-world traceability mandates. In 2025, the European Medicines Agency (EMA) emphasized digital labeling and post-market surveillance in its revision of the Good Pharmacovigilance Practices Module VIII.[iii]

 

3. Stay Ahead of Risk with Global Regulatory Mastery

As biosimilar guidelines evolve, PV professionals must be knowledgeable in global frameworks, especially for products with extrapolated indications or interchangeable status.

Priority capabilities:

• Continuous benefit-risk assessments covering all labeled and extrapolated uses.
• Up-to-date regulatory intelligence across the U.S. Food and Drug Administration, EMA, Pharmaceuticals and Medical Devices Agency, and World Health Organization.
• Lifecycle-specific risk management plans aligned with product expansion.³

Biosimilars approved for multiple indications based on limited clinical trials (i.e., through extrapolation) increase post-market surveillance demands. For example, interchangeability designations enable pharmacists to substitute biosimilars without requiring prescriber notification, but they increase the need for proactive pharmacovigilance systems to detect subtle safety shifts.[iv]

 

4. Real-World Evidence: From Compliance Tool to Strategic Differentiator

Real-world evidence (RWE) is becoming the strategic foundation for biosimilar pharmacovigilance. While spontaneous reports are still valuable, real-time insights from electronic health records, registries, and PSPs enable the detection of signals earlier and provide richer context.

A 2024 meta-analysis of switching studies found no significant safety differences between biosimilars and their reference products, providing critical evidence for educational outreach and formulary adoption.⁶

Next steps for PV leaders:

• Embed RWE into signal evaluation workflows.
• Use AI-driven analytics to detect emerging patterns.
• Educate healthcare providers using evidence from credible, longitudinal datasets.

Biosimilars supported by strong RWE initiatives tend to achieve faster market penetration and encounter fewer safety-related queries, reflecting improved stakeholder confidence and proactive risk management.[v]

 

5. Drive PV Efficiency Without Compromising Safety or Compliance

Although biosimilars offer lower-cost alternatives to branded biologics, they still require intensive PV oversight. Balancing efficiency with regulatory expectations is essential.

Optimization tactics:

• Outsource to PV partners with proven biosimilar expertise.
• Automate case processing, literature surveillance, and aggregate reporting.
• Integrate safety databases across functions to reduce redundancy.³

A recent report found that sponsors leveraging validated automation platforms for pharmacovigilance case processing, an approach applicable to biosimilars, achieved approximately 30 percent cost savings per case without sacrificing compliance or audit readiness.[vi]^,[vii]

 

Pharmacovigilance Leadership Starts with the Right Strategy and Partner

Biosimilars are reshaping the affordability and accessibility equation in biologic therapy. Ensuring their safety requires precision strategies, technology-enabled data systems, and a thorough understanding of patient needs and regulatory expectations. With more than 15 years of specialized experience in biosimilar pharmacovigilance, PrimeVigilance delivers tailored, scalable, and compliant PV solutions. Contact us to discover how we can support your biosimilar product’s post-approval strategy.

 

 

[i] Lisec, I. (2024). Managing pharmacovigilance challenges for biosimilars. PrimeVigilance.

[ii] IQVIA. (2024). Global use of medicines: Outlook to 2028.

[iii] European Medicines Agency. (2025, February). GVP Module VIII: Post-Authorisation Safety Studies (Rev 4). https://www.ema.europa.eu

[iv] FDA. (2024, May 8). Switching between biosimilars and their reference counterparts with Dr. Sarah Yim [Podcast]. U.S. Food & Drug Administration.

[v] IQVIA. (2025). Biosimilars in 2025: The tipping point for adoption. https://www.iqvia.com

[vi] Deloitte. (2019). Transforming pharmacovigilance: Using technology and analytics to enable next‑generation patient safety.

[vii] Deloitte. Deloitte. (2025, March). Future of pharmacovigilance: Efficiency through intelligent automation. https://www2.deloitte.com

[i] Nova One Advisor. (2024, June 17). Biosimilars market size poised to hit USD 150.26 billion by 2033.

[ii] Center for Biosimilars. (2024, April 11). Global biosimilar market projected to reach $1.3 trillion by 2032.