FDA Urged Not to Give Biosimilars Unique Names

From Phramalot


When a biosimilar version of the Avastin cancer treatment becomes available, what should it be called?

The chemical name is bevacizumab, and this is often used by physicians and pharmacists when they discuss the drug. But whether such generic nomenclatures should also become widely used commercial monikers is the subject of an ongoing controversy among drug makers and their major customers.

And so, this week, a coalition of 32 major pharmacies, health insurers, unions and pension plans asked the FDA not to require distinct names for biosimilar medications, arguing that such a move would not compromise patient safety, but could undermine the savings that are expected to be generated as these medicines are introduced into the U.S. health care system.

In a July 1 letter, the agency was told that biosimilars with different names as brand-name biologics could “lead to patient and prescriber confusion,” increase the possibility of medication errors as physicians attempt to prescribe the correct product and slow the adoption of lower-cost medicines that are supposed to help the U.S. save money on its national health care bill.

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; Walgreen and the National Association of Chain Drugs trade group; the CaLPERS fund; and the America’s Health Insurance Plans trade association.

This is only the latest instance in which the FDA has been queried about biosimilar names. Last year, several U.S. senators also wrote the agency to maintain biosimilars should not have commercially different names than brand-name biologics.

At issue is whether biosimilars should be given the same International Proprietary Name, or INN, as brand-name biologics. The global INN system is overseen by the World Health Organization, but its recommendations are not mandatory. This has drug makers and biotechs perturbed, since regulators in different countries can pursue different approaches for identifying biosimilars.

Brand-name drug makers and biotechs want biosimilars to have unique or generic names to distinguish the medicines from the original biologics. In their view, different names would make it easier to track adverse events that might appear in patient records and adverse events reports filed with regulators.

Of course, a distinct name also gives these companies a clear marketing advantage, since established product identities are unlikely to confuse physicians or pharmacists. But generic drug makers worry that the rationales offered by their rivals is really just a gambit designed to blunt competition before biosimilars become an integral part of the U.S. health care market.

In their view, generic drug makers believe creating a new naming standard for biosimilars would cause confusion for physicians and pharmacists, who may stumble when sorting out whether the products are really the same and trying to verify dosing and regimens. They also argue that adverse events and product recalls can already be identified through national drug codes and lot numbers.

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.

“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 coalition writes the FDA. “However, requiring different INNs would create an unnecessary barrier… 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.”

Indeed, a great deal of money is at stake. By 2020, global sales of biosimilars could reach as much as $25 billion in sales and the U.S. is expected to become a bedrock of worldwide demand once the FDA begins approving the medicines.

Meanwhile, drug makers have been busy filing citizen’s petitions with the FDA. The Generic Pharmaceutical Association and Novartis, which owns the Sandoz generic drug maker, want all biosimilars to share the same INN as the original biologics, while Johnson & Johnson argued that biosimilar names should not be identical.



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