Product-specific pharmacovigilance

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Four key considerations for biosimilar interchangeability have been proposed by Dr Brad Jordan, Director of Global Regulatory and R & D Policy at Amgen. He also outlined five principles to address these considerations. The fifth of these principles addresses product-specific pharmacovigilance [1].

Pharmacovigilance V13F21

Issues associated with product-specific pharmacovigilance include:

  • Pharmacy-level substitution of biosimilars can undermine traceability to specific products
  • There is poor connectivity between pharmacy and patient medical records 

A retrospective analysis of adverse event reports assessed the capability of active and passive safety surveillance systems to track product-specific safety events in the US for brand-name and generic enoxaparin. The study found that:

  • 26% reports for generics use were ambiguous (generic drug name only)
  • identification of reports to brand-name or generics manufacturers did not track to volume share

The study authors concluded that ‘the current spontaneous reporting system will not distinguish product-specific safety signals for products distributed by multiple manufacturers, including biosimilars’.

On the other hand, Europe has approved biosimilars with the same non-proprietary names as their reference biologicals for more than six years in a system that has proved effective [2]. The Generic Pharmaceutical Association has also pointed out that ‘adverse events and product recalls for small-molecule and biological drugs already are successfully identified using the national drug code (NDC code), and lot number and company name, and there is no compelling evidence that biosimilars should be handled differently’ [3].

Policy considerations
Dr Jordan believes that the following need to be taken into account when considering pharmacovigilance for biosimilars:

  • Pharmacy practices and health information technology should promote traceability of dispensed biologicals (originator and its biosimilar) to the patient’s health record
  • Prescribers should have ready access to unique identifiers for the dispensed biological

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has stated that ‘pharmacy-mediated interchangeability of biotherapeutics is not appropriate except where, among other things, ‘the patient, pharmacist and the prescribing physician can readily access (for example, via patient health records) unique identifiers for the dispensed biotherapeutic, including a unique product identification and batch information, so as to support pharmacovigilance’.

Related articles
Sound pharmacy practices for biosimilars

Safe switching for biosimilars

Biosimilarity does not mean extrapolation of all indications

Biosimilarity is not interchangeability 

1. Jordan B. Regulatory implications for implementing biosimilar interchangeability: addressing policy and practical concerns. SMi 3rd Annual Biosimilars USA Conference; 16-17 November 2016; Iselin, New Jersey, USA.
2. GaBI Online - Generics and Biosimilars Initiative. Arguments for same INN for biosimilars presented at WHO meeting []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 19]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. FDA issues final guidance on naming biologicals []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 19]. Available from:

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