The FDA is getting an earful from another group intent on saving money on biotech drugs. A coalition of pharmacies, health insurers, unions and pension plans asked the agency to allow biosimilar drugs to carry the same generic names as the drugs they copy. Easy to substitute the biosim for the brand, easier to cut biotech drug spending.
As The Wall Street Journal reports, the coalition wrote the FDA Tuesday to make its case for generic naming. It's not only an economic case; the letter also cited an increased risk of medication errors, and confusion among patients and doctors.
But money is the prime motivator, at least for the pharmacy benefits managers--CVS Caremark ($CVS) and Express Scripts ($ESRX)--insurance industry trade group and self-insuring unions that signed the letter. To support their argument, the letter goosed the FDA to remember the Congressional debate that led to biosimilar legislation in the first place.
"We believe that the legislative intent of the biosimilar approval pathway ... was to support the development of less expensive, but equally effective alternatives to biologic drugs," the letter states (as quoted by the WSJ). Requiring different names for the various biosimilar versions would create "an unnecessary barrier" to use of the less expensive biosim drugs.
"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," the letter states.
Biotech meds are among the most expensive drugs on the market. So, there's powerful motivation for payers to maximize use of biosimilars once they are introduced in the U.S. Powerful motivation, too, for the generics makers lined up to sell those biosims; the Generic Pharmaceutical Association is among those supporting the one-size-fits-all naming.
No surprise, then, that branded drugmakers aren't in favor. Though the motivation is also financial, they have other, non-monetary points to make; for instance, having unique names for each biosim would make it easier to track adverse events associated with particular versions.
- read the WSJ piece
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