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Molly Burich: Biosimilar Naming, Labeling, and Prescribing


Molly Burich, MS, associate director of public policy: biosimilars, pipeline, and reimbursement at Boehringer Ingelheim, discusses current FDA guidance on the naming and labeling of biosimilar treatments.


What impact does current guidance on naming and labeling have on prescribing biosimilars?

I think we’re very thankful that the FDA has released draft guidance on labeling and finalized its naming guidance. These are both important steps. The labels and the names in many ways are how patients and physicians know the product and learn the product, and for physicians how they understand the clinical data behind it.

In terms of labeling, we support that the label should look very similar to the reference product. After all, these are biosimilars to the reference product, so we believe that those labels should look very similar and are pleased with the direction the FDA seems to be taking in labeling. As it pertains to naming, the FDA did end up finalizing the use of a four-digit suffix that is devoid of meaning. I think this is a little bit challenging and this result was not what a lot of stakeholders, including some biosimilar manufacturers, wanted to see. I think we would have preferred that a suffix, if it’s needed, has to be meaningful so that doctors and patients, if needed, can remember it and it’s attributed to the manufacturer.

Unfortunately, that isn’t the way the agency went. So, that’s another opportunity for education to make sure that physicians know our suffix, know that it’s devoid of meaning as much as they can remember it, and that patients certainly understand that while there is a suffix that differentiates it, it doesn’t mean the product is any less safe or efficacious.

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