Large Molecule / Generic

Physicians Side with Big Pharma in Biosimilar Name Debate

The ongoing debate over whether biosimilars should be given the same INN as brand-name biologics has divided the healthcare industry.

By PharmaManufacturing Staff

10 medical societies and a physicians’ group have sent a letter to the FDA requesting that the agency require biosimilars to have distinct names from brand-name biologics.

The ongoing debate over whether biosimilars should be given the same International Proprietary Name (INN) as brand-name biologics has divided the healthcare industry.

Two sides of the debate are as follows:

Brand-name drug makers and biotechs (and now physician groups) want biosimilars to have unique names to distinguish the medicines from the original biologics. Their argument is that different names would make it easier to track adverse events and avoid confusion.

A distinct name, however, also gives pharmaceutical companies a marketing advantage - a point that opposers are quick to make.

Conversely, generic drug makers, major pharmacies, health insurers, unions and pension plans have asked the FDA not to require distinct names for biosimilar medications. They argue that creating a new naming standard for biosimilars would cause confusion for physicians and pharmacists when sorting out whether the products are really the same and trying to verify dosing and regimens.

In their recent letter, physicians stated that they believe different names will make it easier for prescribers to distinguish between medicines that “may differ slightly” and also track adverse events and side effect reports that appear in patient records. In the letter, they point out, "even the same brand of medicine made by the same manufacturer, let alone similar medicines made by different manufacturers, may cause different reactions among patients with the same medical diagnoses and similar physical characteristics.”

The FDA has not yet approved any biosimilars nor issued its policy about biosimilar names.

Read the Physician group letter to the FDA

Read the WSJ article

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