Biosimilars and Off-Label Communication

  • by: |
  • 05/26/2015

Considering the paucity of biosimilar-specific data on the label for Sandoz’s filgrastim-sndz biosimilar, should sponsors be able to discuss their products’ analytical and clinical data with health care providers and payers? And what about with physicians?

When it comes to biosimilars, is off-label now on the table?

Zarxio was approved with labeling that was almost identical to that of Neupogen except for some differences specific to the products’ formulation and presentations The Zarxio label contains all of the same clinical data as that found in Neupogen labeling but none of the clinical or analytical data that supported the finding of biosimilarity to the reference product. But neither the word “biosimilar” nor the name of the reference product are found on Zarxio’s labeling.

Here’s the rub – the FDA has posted on its website hundreds of pages of review documents detailing its findings that Zarxio is highly similar to Neupogen with no clinically meaningful differences. However, the data analyzed in those reviews is nowhere to be found in the Zarxio labeling. The argument is that the absence of such data will hinder a biosimilar sponsors’ ability to use their analytical and clinical data in marketing and promoting the products.

Is this contrary to existing guidance? Technically no. Per a 2012 draft guidance document on scientific considerations in demonstrating biosimilarity, FDA said biosimilar labeling should include all the information necessary for a health professional to make prescribing decisions. This would include a “clear statement” advising that the product is approved as a biosimilar to a reference product, and whether the product has or has not been deemed interchangeable with the reference biologic.  BUT, the labeling-related language was from the final version of the scientific considerations guidance (issued in late April 2015). 

That lack of granularity is particularly irksome to biosimilar manufacturers since being able to discuss the data underlying approved biosimilars will be critical to building support for biosimialrs amongst doctors, patients, and (critically) payers. Can you say FDAMA 114? 

Beyond marketing and formulary concerns, there are also questions over who bears responsibility for updating a biosimilar’s labeling to reflect post-marketing adverse events. And what about the fact that the Sandoz product is not (at least not yet) deemed interchangeable by the FDA?

A side-by-side assessment of biosimilars and their reference product is a logical and appropriate exercise. Will it be considered violative, off-label communications?

Should it be specifically called out in 21st Century Cures? Should it await PDUFA VI? Or will the agency revise it’s current position of it’s own accord. And what will the impact of this issue be on biosimilar nomenclature?

Inquiring minds want to know.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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