PBSA Asks FDA to Change Biosimilars Materials, But Other Patient Groups Cry Foul


The Patients for Biologics Safety and Access (PBSA) is calling on the FDA to revise its prescriber-directed online educational materials on biosimilars. However, not all patient groups agree with PBSA’s stance.

The Patients for Biologics Safety and Access (PBSA) is calling on the FDA to revise its prescriber-directed online educational materials on biosimilars.

The PBSA’s feedback to the FDA includes a red-lined document of the FDA’s materials. The organization’s proposed edits include, among others, adding a statement that the FDA does not require data on the safety of multiple switches to and from a reference product or other approved biosimilars or interchangeable products and adding a side-by-side comparison chart showing differences in the application and approval process for biosimilars versus their reference products.

It also proposes adding the phrase “the assumption is that” before the statement “It is scientifically justified to rely on certain existing scientific knowledge about the safety and effectiveness of the reference product to support approval.” PBSA also asks the FDA to delete a statement that prescribers and patients should have no concerns about using biosimilars instead of reference products.

However, not all patient groups agree with PBSA’s stance. Louis Tharp, co-founder and executive director of the Global Healthy Living Foundation and its arthritis community, CreakyJoints, told The Center for Biosimilars® in an interview that his organizations strongly disagrees with PBSA on this matter.

“First of all, [patient groups] all correspond with FDA, CDC, and other agencies—[both] state and federal. We think that’s important. The difference here is that we don’t put out a press release about it. Publicizing the details of an educational program makes us wonder whether the PBSA is trying to disparage biosimilars. If that was the intent of that news release, we have to stand up and say we can’t agree with that,” said Tharp. “We need to understand what the motives are, and we need to be sure that biosimilars have every opportunity."

While Tharp said that he would welcome continued efforts by the FDA to help pave the way for greater adoption of biosimilars—including continued educational efforts—so far, he would give the FDA and Commissioner Scott Gottlieb, MD, an “A” for their record on biosimilars.

Tharp also had qualms about PBSA’s call for congressional oversight hearings on the safety of biosimilars. “We follow biosimilars in Europe, Asia, and the United States, said Tharp. “The safety record of biosimilars in Europe and Asia is exemplary. It’s stellar.”

Furthermore, a representative of the International Foundation for Autoimmune & Autoinflammatory Arthritis (IFAA), a member organization of PBSA, was quoted in PBSA’s press release as speaking in favor of the proposed changes to the FDA’s materials. However, the representative told The Center for Biosimilars® via email that IFAA stands in support of both biosimilars and the FDA, and that IFAA has instructed the PBSA to remove the quote from its materials.

The Biosimilars Forum also weighed in; Juliana M. Reed, president of the Biosimilars Forum, told The Center for Biosimilars® in an email that “There are more than 700 million patient days of data worldwide that demonstrate biosimilars are as safe and effective as their reference products. Europe has benefited from biosimilars for over 10 years, and biosimilars have lowered drug costs and increased patient access in over 80 countries." Reed added that "The Forum supports the efforts by the FDA to help health care providers gain a better understanding of these important products and the approval process they undergo."

PBSA could not be reached for comment.

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