An FDA official has said that the agency expects interchangeable biosimilars to come to market within 2 years and that the first interchangeable biosimilar will likely be reviewed by an FDA advisory committee of outside experts.
An FDA official has said that the agency expects interchangeable biosimilars to come to market within 2 years, possibly sooner, and that the first interchangeable biosimilar will likely be reviewed by an FDA advisory committee of outside experts.
Speaking at the Drug Information Association’s (DIA) annual conference in Chicago, FDA biosimilars lead Leah Christl, associate director for Therapeutic Biologics, OND Therapeutic Biologics and Biosimilars Team, also confirmed that the FDA has received 14 applications from 9 companies for biosimilars.
Christl said the FDA is reviewing industry stakeholders’ comments on the agency’s draft guidance on biosimilar interchangeability released in January 2017, and expects to issue either a revised guidance or a final guidance within 2 years. Industry stakeholders have noted several issues in their comments, including the naming and labeling for interchangeable products as well as the relationship between multiple interchangeable products for the same reference product.
Stakeholders want the FDA to address the issue of naming interchangeable biosimilar products in its final interchangeability guidance. The FDA’s final naming guidance issued in 2017 states that biosimilar and innovator biologic products will have the same core nonproprietary names followed by a distinguishable, but meaningless, lowercase 4-letter suffix—a ruling disliked by both biosimilar makers and innovators. Many stakeholders urged the FDA to use the same naming rules for interchangeable products as for biosimilar products.
The Pharmaceutical Research and Manufacturers of America (PhRMA), a trade organization that represents the pharmaceutical industry, noted that suffixes of interchangeable products should remain different from those of reference products to distinguish them from each other for patient safety and tracking purposes. “If multiple interchangeable versions of a single reference product were assigned the same suffix without an FDA determination that they were interchangeable to each other, there might be inadvertent substitution of these products,” PhRMA noted.
Stakeholders also pointed out that the FDA’s draft interchangeability guidance did not address labeling. They want biosimilar labeling to include interchangeability statements identifying whether or not interchangeability has been evaluated for the biosimilar, and include a definition for interchangeability.
There is also a demand for clarity on handling multiple interchangeable biosimilar products of the same reference product—stakeholders want the FDA to take steps to ensure that only an interchangeable biological product and its reference product are subject to automatic pharmacy substitution. Amgen, for example, asked the FDA to include a statement in the guidance that interchangeability does not reflect any relationship with another interchangeable product to the same reference product.
Finally, stakeholders asked the FDA to address confusion over physician-mediated switching, which is possible for interchangeable and non-interchangeable biosimilars, and pharmacy-level substitution, which is possible for interchangeable biosimilar products.
With patient protection their greatest concern, patient groups demanded the FDA take steps to protect patients from nonmedical switching involving non-interchangeable biosimilars. A number of comments from patient groups stated their concern that payers were, in effect, mandating pharmacy-level substitution for non-interchangeable biosimilars by removing innovator/reference products from formularies.
The Biologic Prescribers Collaborative has provided interchangeability recommendations to the FDA. Visit our infographic on the recommendations here.