Battle continues: PBMs urged FDA about biosimilars naming in the U.S.

July 9, 2014 2:34 PM

U.S. regulatory watchdog, FDA received a letter from a coalition of 32 major pharmacies, health  insurers, pension plans and unions last week.

The organizations urged the U.S. FDA not to require distinct names for each biosimilar, declaring that such a move is not needed for ensuring the safety of the patients. They also added that, this requirement would not help the country to cut the costs of biologics.

Among those signing the letter were two large unions – AFL-CIO and AFSCME: two of the largest pharmacy benefit managers – CVS Caremark and Express Scripts; Walgreens and the National Association of Chain Drugs trade group; the CalPERS fund; and the America’s Health Insurance Plans trade association.

In their letter to the FDA, “We believe that biologics and biosimilars should be required to have the same INN. Requiring different INNs for biologics and biosimilars could lead to patient and prescriber confusion, increasing the possibility for medication errors and would also effectively seperate the biosimilar from the existing safety information about the underlying molecule”, the coalition wrote.

“There is already a precedent for shared names (e.g., erythropoietins, somatropin, interferon), which has not resulted in any known issues. Shared INNs are also safely and effectively utilized in EU, Canada, Australia and Japan”, the letter states.

The FDA, however, has not yet established a naming policy, suggesting the agency is waiting for cues from the WHO. The Biologics Price Competition and Innovation Act, which was implemented as part of the Affordable Care Act, created a regulatory pathway for approving biosimilars, but did not specifically address a naming protocol for the medicines.

The letter can be reached from here.

Source: WSJ

 

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