What’s in a name? A lot if you’re talking about biosimilars. The FDA recently received a letter from a 32 member coalition consisting of major pharmacies, health insurers and unions asking that they not require biosimilars to be given different names than biologics. The group claimed that with distinct names for biologics and biosimilars, there’s an increased risk for medication errors as well the potential to slow the adoption of cost-saving drugs.
The letter states, “Requiring different INNs (International Nonproprietary Names) for biologics and biosimilars could lead to patient and prescriber confusion, increasing the possibility of medication errors, and would also effectively separate the biosimilar from existing safety information about the underlying molecule.”
This request comes less than a year after the US Senate made a similar request to the FDA. The letter from the senate states that “There is already a precedent for shared names (e.g., erythropoietins, somatropin, interferon), which has not resulted in any known issues.” The more recent letter reiterated that argument and while also pointing to the fact that shared INNs have been successfully applied in the EU, Canada, Australia and Japan.
There is also a concern that unique names could confuse both patients and prescribers and potentially hinder the adoption of these biosimilars and the cost savings associated with them. The letter states there is anywhere between $42 billion and $108 billion in savings at stake over the first ten years of the biosimilar market.
One group not on board with utilizing the same INNs? Brand name drug manufacturers. A distinct marketing advantage lies within these names and drug manufacturers are not willing to share them. They claim that having unique names would make it easier to track adverse events in patient records—A claim refuted by generic drug makers who say these events can be identified through national drug codes.
While they’ve yet to institute a naming policy, indications are they may be waiting for a cue from the World Health Organization. The INN System is overseen by the WHO, however its recommendations are not mandatory.
We’ll have more on latest in the biosimilars industry at the Business of Biosimilars conference. Join us October 20-22 in Boston, MA. Download the agenda here to see what’s on tap.
SAVE $100. Register here and use code XP1986BLOG.
Join us on LinkedIn
Share this article with your social network, just click below to share now!