EMA Adopts New Biologic, Biosimilar Pharmacovigilance Guidance

Regulatory NewsRegulatory News | 15 August 2016 |  By 

The European Medicines Agency (EMA) on Monday announced new recommendations for monitoring the safety of biologics and biosimilars. The guidance will take effect on 16 August 2016.

The new recommendations are part of a new chapter of EU good pharmacovigilance practice (GVP) guidelines, titled Product- or population specific considerations II: Biological medicinal products.


Pharmacovigilance is the process of monitoring the use of drugs after they have entered the market. In particular, regulators, companies and healthcare providers are responsible for monitoring drug safety and reporting suspected adverse events.

In 2010 and 2012, the EU introduced and adopted new directives and regulations amending its pharmacovigilance requirements.

According to a recent report by the European Commission, efforts to improve pharmacovigilance activities in the EU have been effective since the new legislation went into effect, citing an increase in the number of individual case safety reports made to the EudraVigilance system by both patients and health care providers.


The new EMA guidance provides drugmakers with recommendations on biologic-specific challenges, and applies to all biological drugs and biosimilars, but does not cover vaccines or advanced therapy products, such as cell or gene therapies.

Because the new guidance does not introduce any new requirements, EMA says it is meant to be read "alongside the process-related GVP Modules when developing and implementing pharmacovigilance for biologicals," to ensure that companies address the unique challenges associated with such products.

For example, EMA says that careful attention should be paid to immunogenicity, and should be reflected in a company's risk management plan. While both drugs and biologics have the potential to cause immunogenicity, the risk is far greater for biologics and may require additional pharmacovigilance activities.

"Depending on the nature of any potential immunogenicity and the data that generated the concern, or the nature of the missing information, the additional pharmacovigilance activities should have clearly defined objectives," EMA writes.

In terms of manufacturing, EMA says that changes to the process could require companies to produce additional non-clinical or clinical data that may need to be factored into a risk management plan.

"These potential changes are relevant not only within a product (e.g. 'change' in quality specifications over time), but also across products with the same international non-proprietary name (INN). In the long-term post-authorisation period, the originator, biosimilar(s) and related biological product(s) may potentially exhibit different safety profiles as these products evolve through their life-cycle," the guidance says.

Even minor changes to a manufacturing process can potentially have unpredictable but significant clinical effects, EMA adds. And in cases "when the comparability exercise or evaluation has not necessarily identified a potential impact of clinical relevance," EMA recommends submission of an updated risk management plan, though "the variation to the manufacturing process may still be appropriate based on a risk analysis or previous experience."

The updated version of the guidance (from July) also notes that the product name and batch number of an administered biologic should be recorded by the healthcare professional and be provided to the patient.

"This is particularly important in cases when different versions of the same active substance are available concomitantly on the market and interchangeably used by the same patient," the revised text reads.

The guidance also addresses issues related to product stability, traceability, risk management, adverse event reporting and signal management. In addition to the guidance, EMA on Monday released 92 pages worth of industry comments on the guidance.


Product- or population specific considerations II: Biological medicinal products


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