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.
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