Strategic Pharmacovigilance Checklist for Biosimilar Safety in 2025

The biosimilar market is growing rapidly due to rising healthcare demands, patent expirations of reference biologics, and a focus on cost-effective therapies. Pharmacovigilance for biosimilar products is critical to ensure patient safety, monitor potential risks, and support healthcare outcomes. This blog presents a strategic pharmacovigilance checklist for biosimilar 2025 to help PV teams proactively manage biosimilar safety using regulatory guidance and best practices.

Maintaining patient safety is not only a legal requirement but also a strategic imperative, as the biosimilar market expands rapidly. Pharmacovigilance teams face increasing pressure to identify, evaluate, and mitigate risks associated with the biosimilars due to evolving global regulations, complex manufacturing process and rising market competition. The biosimilar market is predicted to double from USD 41.97 billion in 2025 to USD 97.32 billion by 2030, with Europe holding the largest market share of 37%.

Key Steps to Implement Pharmacovigilance Checklist for Biosimilar Safety

Below is a comprehensive checklist for PV teams to proactively manage biosimilar safety in 2025.

Risk Management Plan (RMP)

Create a unique RMP to identify known and unknown potential risks that can occur at any stage of the product development.
Ensure that RMPs designed for biosimilars focus on key issues such as immunogenicity, and product variability.
When reference product’s RMP changes, immediately update its complete safety profile.

Immunogenicity Oversight

Prioritize immunogenicity in all safety monitoring activities.
Focus on post-marketing studies and specialized testing to identify anti-drug antibodies and associated side effects.
Ensure the RMP describes risk mitigation strategies and monitoring approaches for immunogenicity.

Traceability & Product Identification

Each batch must have its own unique identifiers such as barcodes, brand names or suffixes (US four-letter INN suffix) to easily identify reference medicines and biosimilars.
Make sure these identifiers are properly updated in EHR systems, AE reports, and patient records.
To accurately denote adverse events, use digital tools such as lot-tracking apps and barcode scanning in patient support programs and pharmacies.

Advanced Signal Detection Techniques

Integrate data from registries, patient-reported outcomes, and electronic health records into pharmacovigilance processes.
Use AI and ML tools such as PVLens to improve risk assessment, signal processing with the help of real time data & put the data into MedRA Dictionary.
Use algorithms to remove outdated safety reports (e.g., VigiMatch) for data integrity.
Use AI and ML tools to improve risk assessments signal processing and detection.
To detect safety signals more precisely, use international pharmacovigilance databases such as the EUs EudraVigilance and the WHOs VigiBase.

Global PV Networks

Keep up to date with the latest biosimilar PV requirements from regulatory agencies (FDA, EMA, WHO, and CDSCO).
Learn about the changes such as EMA’s focus on real-world safety data, standardized PSUR templates, and updated risk benefit frameworks.
Match PV strategy and RMP to the product’s lifecycle.

Regulatory Grade Reporting

Submit Periodic Benefit-Risk Evaluation Report (PBRERs) or Periodic Safety Update Reports (PSURs) as per the regional deadlines. For instance, India requires submission of PSURs every six months for two years after approval.
Adjust safety data and RMP according to regional landscape and logistical issues (like variations in temperature).
Harmonize PV with both international standards and regional frameworks in places like India (e. g. CDSCO and PvPI)
Utilize national initiatives such as the Materiovigilance Programme and India’s PvPI to assist in the monitoring of adverse events.

Process Automation & Efficiency

Combine safety database information from manufacturing, quality, and regulatory processes to conduct audits efficiently.
To boost efficiency and lower error rates, automate case processing, literature surveillance and reporting.
Use specialized platforms to manage the complexities of biosimilars, improve efficiency, reduce costs, and streamline audits.

Stakeholder Engagement and Public Awareness

Train healthcare professionals to use product and batch identifiers to accurately report adverse events.
Apply pharmacovigilance best practices and identify adverse events linked to immunogenicity.
In environments with limited resources where underreporting occurs, encourage patients to report adverse events.

Naming & Labelling Precision

To prevent misunderstandings and to trace back to the original product, focus on accurate product identification code, such as brand names, batch numbers and naming conventions.
Recognize how different jurisdiction names differ across each other (e. g. EMA naming models versus FDA four-character suffix) and adjust accordingly.
Ensure that PSURs PBRERs and PASSs are delivered in a timely and organized manner.

Cross-Functional Collaboration

For EU-marketed biosimilars, appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) with knowledge of all PV processes to monitor the ongoing process 24/7.
Adhere to GMP standards and serve as the authority for pharmacovigilance compliance
Control medical device issues with the help of initiatives like India’s Materiovigilance program.

Regulatory guidelines to be followed Pharmacovigilance for Biosimilar Safety

Pharmacovigilance for biosimilars follows the same regulatory standards as for all medications, with a focus on risk management, adverse event reporting and post-marketing surveillance. It primarily addressing factors such as immunogenicity for biologics.

European Union (EU): For biological products such as biosimilars, the ‘European Medicines Agency (EMA) Guideline on Good Pharmacovigilance Practices (GVP)-Product or Population-Specific Considerations’ is applied for factors- immunogenicity and risk management strategies.
India: The ‘Guidelines on Similar Biologics’ by CDSCO in India focus on specific topics such as pre- and post-market specifications like case processing and safety monitoring for biosimilars.
United States (US): The International Council for Harmonization (ICH) offer comprehensive frameworks for checking quality and safety of new drugs, while the FDA monitors biosimilar safety, with the help of its pharmacovigilance system.
The World Health Organization (WHO): Allows continuous safety monitoring and provides specific guidelines, followed worldwide for biosimilar evaluation, as per regulatory requirements.

Why Global Pharmacovigilance Strategies Fail Without Local Nuance: Lessons from Asia, LATAM, and MENA

Strategic Approaches for Maintaining proper PV Checklist

Stay Ahead of Evolving Guidelines
Ensure Robust Data Collection & Traceability
Leverage Digital Technologies
Promote Collaboration and Information Sharing
Provide Continuous Education and Training
Focus on Risk Management
Integrate AI-Driven Systems

Conclusion

A proactive integrated pharmacovigilance strategy involves digital innovation, regulatory compliance and stakeholder engagement to manage the complex biosimilar market in 2025. A proactive pharmacovigilance strategy ensures that biosimilars are used safely, maximizing benefits while minimizing risks through integrated PV approaches.

How can DDReg help?

At DDReg, we provide pharmacovigilance services through multiple approaches that ensure safety and efficacy of pharmaceutical products throughout their lifecycle.