Survey: Current Labeling of Biosimilars Inadequate

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Product labels should include more information on extrapolation, interchangeability, and the original source of clinical trial data, according to a survey of those in charge of dispensing medications.

Current labeling requirements for biosimilars are not transparent enough, according to a new survey of more than 400 pharmacists. The survey, conducted by the Alliance for Safe Biologic Medicines (ASBM), asked pharmacists to rate the importance of the appearance of certain criteria on a biosimilar’s label, including information on whether or not a product is identified as a biosimilar, whether it is interchangeable with existing products, whether the original source of the data on the label are from the originator company or the biosimilar sponsor, and whether the data apply to one indication or all indications of the originator product.

The survey revealed that 81% of pharmacists think it is important to clearly identify a product as a biosimilar, and although there have not yet been any products to win the designation, 88% think it is important to indicate whether a product is interchangeable or not.

When it comes to data from clinical trials, 76% of pharmacists said it was important to include information on which indications a biosimilar was studied, and 69% wanted more information about whether the source of the data was from the originator company (as is the current practice with small-molecule compounds), or was from clinical trials involving the biosimilar.

“We hope these survey results positively inform the FDA as it drafts its upcoming labeling guidance,” said Dean Jordan, ASBM advisory board member, during the World Health Organization’s 61st Consultation on International Nonproprietary Names in Geneva on Oct. 13, 2015.


The label for the first FDA-approved biosimilar, Zarxio (filgrastim-sndz), does not currently include any of the aforementioned information. The data on Zarxio’s label are from reference product studies; the inclusion of the data on the biosimilar’s label uses a similar approach to that of the one used for generic applications. In other words, the labeling that FDA approved for Zarxio relies entirely on studies involving Neupogen (filgrastim) and does not acknowledge that the studies were not conducted with Zarxio.

The ASBM survey results echo many of the sentiments included in the AbbVie Citizen Petition to FDA from June 2015, which, among other things, pushed for labels to include "data developed to support licensure of the biosimilar, along with information adequate to enable prescribers to distinguish data derived from studies of the biosimilar from data derived from studies of the reference product." In response to the petition, Sandoz (maker of Zarxio) countered that analytical data aren’t necessary in biosimilar product labeling to inform prescribing decisions.

Source: ASBM