Pharmacovigilance of Biologics in a Multisource Environment

It is important that systems are in place to ensure that appropriate and comprehensive records are kept for use of all medications. It is fundamental to an effective pharmacovigilance system that patient medical records contain sufficient information to identify which medication has been prescribed, when it was administered, and at what dose. The availability of biologics from multiple sponsors has raised questions by some health care providers about the ability of current pharmacovigilance systems to trace specific biologics. In this article, periodic safety update reports were used to assess current postapproval safety monitoring for 3 biosimilars (epoetin alfa, somatropin, and filgrastim) that collectively represented nearly 350 million patient days of treatment worldwide. The reference products have each been marketed for over 10 years, forming a strong baseline of postmarketing safety data against which the safety of biosimilars can be compared. Published data from Denmark were also reviewed as additional evidence of how current pharmacovigilance systems are able to attribute adverse events to particular medicines. Collectively, the data show that spontaneous adverse drug reactions are reported by brand name in the majority of cases and are attributable to a specific medicine. Also discussed are the informational elements critical to monitoring biologics, or indeed any medicine, to ensure the availability of complete information so medicines that a patient has received can be quickly identified should a safety event occur. We support the addition of a single data element, the batch/lot number, to enhance the value of current pharmacovigilance systems. Adoption of 2-D barcodes in the European Union (EU) and standardized numerical identifiers in the United States addresses this need, since they include batch/lot numbers. These identifiers are already being implemented in the United States and the EU to improve patient safety, reduce medication errors, facilitate anticounterfeiting, and enable effective product recalls and adverse event reporting. Importantly, electronic identifiers will ameliorate safety reporting concerns with respect to biosimilars, while concurrently achieving these much broader public health objectives through more complete pharmacovigilance data.

This work was funded by Sandoz, a Novartis division. The authors were fully responsible for the content, editorial decisions, and opinions expressed in this article. No author received an honorarium related to the development of this manuscript. Sagi and Cohen are employees of Sandoz, and Woollett is an employee of Avalere Health. Study concept and design were contributed by Sagi and Woollett, along with Cohen. Data were primarily collected by Sagi, along with Woollett, and data interpretation was provided by all the authors. The manuscript was written by Woollett, along with Sagi and Cohen, and revised by Sagi and Cohen, along with Woollett.