In FDA petition, Pfizer blasts 'misleading' biosims messages from J&J, Amgen and Roche

Pfizer building
Pfizer is asking the FDA to issue guidance requiring accurate communications about biosimilars. (Tracy Staton)

It’s not often that drug industry giants end up on opposite sides of a copycat-brand battle, but biosimilars have leading pharmas doing just that. And so far, no biosims maker has been more aggressive about attacking its fellows than Pfizer.

Witness a new FDA citizen petition Pfizer filed this week. The drug giant blasts industry peers Amgen, Johnson & Johnson and Roche for allegedly disseminating “false and misleading” info to sow confusion about biosims in the U.S. 

Pfizer has a vested interest in promoting biosiomilar competition. Its Hospira unit has spent years developing copycat biologics, and so far its first launch, a Remicade copy dubbed Inflectra, hasn't gained much ground. The company also has late-stage biosim candidates to AbbVie's Humira, plus Roche's Avastin and Rituxan.

The drugmaker is asking the FDA to issue guidance to ensure accurate communications to doctors and patients about biologic copycats. As Pfizer notes, the federal government has been working to bolster drug competition to provide cost relief for patients—and the so-called misleading information on biosims is undermining that effort. 

To support its argument, Pfizer offers several examples. A J&J patient brochure confuses the issue by saying biosims act in a way “similar” to J&J’s Remicade, Pfizer argues. But the company points out that regulators require biosims to be highly similar to their reference products, using the same mechanism of action. 

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RELATED: FDA chief Gottlieb blames drugmakers for ‘anemic’ biosimilar market

Meanwhile, an Amgen video says switching from one biologic to another “carries risks.” 

“Switching drugs is not a good idea if your medicine is working for you,” the video says, Pfizer's petition claims.

An Amgen spokesperson responded that the company is "committed to educational communication of factual, balanced information regarding biosimilars" and works to build confidence in the products. The company is "fully committed to the success of the biosimilars market," she added.

Pfizer also flags a Genentech website saying the FDA requires biosims to be “highly similar, but not identical” to their branded counterparts. Pfizer says this phrasing doesn't state that an FDA-approved biosimilar “must have no clinically meaningful differences from the reference product.” Genentech is a unit of Swiss drug giant Roche.

In all, Pfizer argues the statements “and the net impression conveyed by such materials, create undue confusion as to biosimilarity and interchangeability, inflate the risks associated with a physician-directed switch to a biosimilar, and cast doubt on the safety and efficacy of biosimilars generally.” 

As the drugmaker points out, biosim uptake in the U.S. has significantly lagged Europe. Research there has found that biosims bolster patients' access to branded and biosim options alike. 

Pfizer's petition urges the FDA to clearly outline biosimilar descriptions that are “inappropriate because they would be false or misleading.” If a sponsor company includes language that a biosim is “highly similar,” but not “identical,” Pfizer requests that the messaging should include a disclosure that there are no “clinically meaningful differences" between the products. 

The drugmaker may have an enthusiastic audience at the FDA. Previously, agency commissioner Scott Gottlieb said the "drug industry didn’t build its success by being business naïve."

"But that doesn’t mean we need to embrace all of these business tactics, or agree that they’re appropriate," he added.

The FDA citizen petition isn’t Pfizer’s only attempt to bolster the struggling U.S. biosimilars market. The drugmaker is also suing J&J for what it calls “anticompetitive” contracting to protect Remicade from biosim competition.  

Pfizer launched Inflectra back in 2016 and hasn’t stolen much market share from the J&J med. The company says J&J has tied discounts on Remicade and its massive patient pool to the stipulation that payers avoid Remicade biosims. In effect, competitors have been shut out, Pfizer argues. J&J petitioned to dismiss the case, but a judge recently ruled the lawsuit may proceed.  

Pfizer is in an unusual position because it has made a bet on biosimilars, but it also markets branded biologics. Novartis and Amgen also market branded biologics as well as biosimilars. 

Editor's note: This story was updated with a statement from Amgen.

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