Pharmacovigilance and Regulatory Affairs

Safety Monitoring of Biologics and Biosimilars

Biologics and biosimilars present unique challenges in pharmacovigilance due to their complex structures, manufacturing variability, and immunogenic potential. Unlike small-molecule drugs, biologics can induce immune responses that vary by patient population and product handling, making continuous safety monitoring essential. Post-marketing surveillance for biologics must address issues such as traceability, batch-specific effects, and rare but serious adverse events. Pharmacovigilance systems must distinguish between innovator biologics and biosimilars, especially when multiple products share the same active ingredient but differ in structure or formulation. This requires enhanced pharmacovigilance coding, product identification strategies, and comprehensive patient follow-up.

In biosimilars, regulatory expectations include comparative safety assessments with reference products and robust risk management plans. Stakeholder education is vital to ensure appropriate reporting and understanding of interchangeability. Collaboration between regulators, manufacturers, and healthcare providers plays a key role in building trust in biosimilars while safeguarding public health. As biologics dominate the pharmaceutical pipeline, their safety oversight demands tailored and scientifically rigorous pharmacovigilance strategies.