FDA's new draft guidance on naming biosimilars already drawing pushback
- The FDA has issued new proposed guidance on biosimilar naming. One main goal of the guidance is to prevent inadvertent substitution of non-interchangeable products.
- Another goal of the guidance is to make it easier to track drug utilization and adverse events.
- The draft guidance already has its critics. For instance, the Biosimilars Council, headed by Dr. Bert Liang, disagrees with the guidance.
Stakeholders have been waiting for what seems like a long time for guidance on naming biosimilars, and now that the draft guidance has arrived, not everyone is pleased. Dr. Bert Liang, Chairman of the Biosimilars Council does not support the proposal of using suffixes as a distinguishing feature between biologics and biosimilars.
In a statement published on the Generic Pharmaceutical Association's web site, Dr. Liang said, "Because the Biosimilars Council shares the agency’s deep commitment to patient safety, we believe that biologics and biosimilars should be required to have the same International Nonproprietary Name (INN) with no added 'FDA-designated suffix.'
"Adverse events and product recalls for small-molecule and biologic drugs already are successfully identified using the national drug code (NDC code), and lot number and company name, and there is no compelling evidence that biosimilars should be handled differently."
He continued, "There is already a precedent for shared names (e.g., erythropoietins, somatropin, interferon), which has not resulted in any known patient safety issues. Shared INNs without suffixes are also safely and effectively utilized in EU, Canada, Australia, and Japan. Adding a random collection of letters to the product’s nonproprietary name confers no additional safety benefit, and in fact would require the healthcare professional to be armed at all times with a code-breaking reference."
There are other potential problems as well, such as dealing with biologic drugs that have already been approved, but do not have suffixes—and the fact that this proposal could create a real barrier for interchangeability.
It's not a done deal yet. Note that this is draft guidance, and the FDA is seeking public comments—which it is sure to get in droves, judging by early pushback.