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.
Transcript:
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I think we’re very thankful that the FDA has released draft guidance on labeling and finalized its naming guidance.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.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.