Due to the complexity of biosimilars and because multiple companies are developing biosimilars of the same reference molecules, an infrastructure that supports the ability to track and trace the use of different biologics and provides physicians with detailed, product-specific labels, is important to enable optimal patient safety monitoring and prescribing.1
All biologic medicines, including biosimilars, present at least some risk of an unwanted response to the medicine, where the patient reacts against the proteins in the medicine. It is important to assure that the adverse event is attributed to the correct biologic manufacturer.
For this reason, it is important to have pharmacovigilance programs in place that can support the product profile beyond clinical trials.
Naming and Traceability1-3
An important tool to track and trace the use of a medicine given to a patient is a distinguishable International Non-proprietary Name (INN) for each medicine. INNs were developed to facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients.
INNs also help prevent pharmacists from inappropriately substituting one biosimilar for another biosimilar or the reference biologic medicine. And in the case of an adverse event, INNs allow the product to be traced back to the manufacturer.
Amgen, a developer of both originator products and biosimilars, believes prompt identification of medicinal product problems can be enabled by distinguishable non-proprietary names, which will ultimately enhance patient safety.
Biologic Labels Must Answer Important Questions4
Whether a biologic medicine is an original reference product or a biosimilar, the label needs to answer important questions to ensure physicians have access to critical product information for prescribing. A physician’s ability to meet each individual patient’s clinical needs will be aided by detailed and product-specific labels for all biologics. As such, biosimilar labels that meet the following guidelines may be helpful for physician prescribing practices:
- (1) Identify as biosimilar but not designated as interchangeable, or (2) identify as biosimilar and designated as interchangeable
- Identify the reference product
- Clearly identify the source of the clinical data included on the label (reference product sponsor or biosimilar sponsor)
- Allow for clinical data generated by the biosimilar sponsor to be referable—through a mechanism such as a “summary of the totality of the evidence” document or directly on the label