“Requiring different INNs 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,” the group said in its letter to FDA Commissioner Margaret Hamburg last week.
The group - which includes pharmacies CVS Caremark and Walgreens, the US Public Interest Research Group, state employee retirement systems from California, Ohio and Texas, as well as GPhA (the Generic Pharmaceutical Association) – stress the cost savings element of INNs for patients, prescribers and dispensers in its letter.
With the average daily cost of a brand name biologic product being about 22 times greater than a traditional drug, the group claims that patients, prescribers and dispensers of these drugs “need to be able to easily identify which drugs bear a relation to one another in order to maximize the potential savings from the biosimilar approval pathway.”
A recent study by Express Scripts, which also signed the letter, found that in California alone, patients and payers could save $27.6bn over the next 10 years from the introduction of biosimilars to replace biologics whose patents expire in the near future.
Spending growth also seems to be a factor for the groups, with US average annual spending growth from 2002 to 2007 spiking 16% for biologics, compared with 3.7% for other drugs. “This price trend will be a significant cost driver for public health care programs including Medicare and Medicaid,” the group says.
In addition, the group contends that if the FDA is willing to call a biosimilar and a biologic interchangeable, then the products should have the same INNs to ensure this status.
“Requiring different INNs would create an unnecessary barrier to the benefits of FDA-determined interchangeability,” the group says.
A majority of EU member states agree with this group of stakeholders, noting that separate INNs could undermine the trust of health professionals and the public. The EU call follows support for the same INNs from Hospira and Novartis.
However, others in industry – including Johnson & Johnson, AbbVie, Genentech and Amgen -- have raised arguments against using the same INNs because of the confusion it might cause for patients and physicians who could wrongfully assume the products are the same because of their INNs.
The industry heavyweights, who are backed by industry group BIO, also said they think separate INNs are necessary for accurate post-market surveillance.
The battles between industry and stakeholders are also playing out among state legislators, and seem likely to continue until the FDA sets a precedent. However, there isn’t a timeline for such a precedent, or for the agency to begin approving biosimilars.
FDA spokesman Kristofer Baumgartnertold us: “FDA is currently considering the appropriate naming convention for biosimilar and interchangeable products licensed under the pathway established by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).”