Amid COVID-19 Fears, Expert Panel Highlights Need for Biosimilars in the United States

Multiple challenges impede the uptake and development of biosimilars in the US market, according to a panel of experts who spoke at the Biosimilars: Breaking Through the Barriers symposium March 10, 2020, in Washington, DC.

As the COVID-19 pandemic spreads, concerns have arisen about the availability of active pharmaceutical ingredients that are essential for drug manufacture, owing to manufacturing slowdowns, border closings, hoarding, and protectionism.

Marc Siegel, MD, of NYU Langone Health in New York, New York, said it’s possible that biosimilar supplies may be more plentiful than other types of medicine. Siegel spoke via video link due to NYU Langone Health’s 60-day, COVID-19—related travel ban.

“I am deeply disturbed to find that without China, I may lose access to my most crucial antibiotics and blood pressure medicines. It is time to consider effective alternatives that are cheaper, beginning with biosimilars and generics,” he said.

He highlighted the struggles surrounding drug production in China as the coronavirus crisis continues to unfold and how it has affected his work.

Besides Siegel, who served as a co-moderator, the panel consisted of Anna Hyde, vice president of Advocacy and Access for the Arthritis Foundation of Atlanta, Georgia; Annette Guarisco Fildes, president and chief executive officer of The ERISA Industry Committee, Washington, DC; Sameer Awsare, associate executive director of The Permanente Medical Group of Oakland, California; and Pam Traxel, senior vice president of Development Resources for the American Cancer Society-Cancer Action Network in Washington, DC.

The panel’s other co-moderator was Juliana Reed, vice president and global corporate affairs lead for Inflammation & Immunology at Pfizer in New York, New York.

The panelists discussed the knowledge barriers preventing US biosimilar uptake, including terminology confusion. Through focus groups, roundtables, and surveys, investigators have found that terms such as "biosimilars," "biologics," and "interchangeability" are not household terms for most people, said Hyde.

“Patients aren’t going to go in saying, ‘I heard about this biosimilar.’ The provider is really a key component there, in even raising the conversation,” he aid, adding that good outcomes depend on providers having knowledge and knowing how to frame the biosimilars discussion.

“If a patient is walking out of that exam room, feeling any kind of connotation about biosimilars that's even remotely negative, they're more likely to have the nocebo effect,” Hyde elaborated. The nocebo effect occurs when a patient’s negative opinions about a drug lead to the drug being ineffective.

Awsare discussed the scientific barriers that lead to patients and providers lacking confidence in biosimilars, saying that studies coming from Europe or the US Department of Veterans Affairs aren’t convincing enough for them and that further studies from US-based institutions, such as Kaiser Permanente, are needed.

He also emphasized that “having the clinical input up front, educating our physicians and patients, giving the physicians and patients time [to make decisions]" have led to an increase in biosimilar uptake, as has saying, "‘It's OK. If this doesn't work, we'll switch you back to the originator product.’”

Traxel talked about the importance of biosimilars in oncology, calling these drugs “the backbones of cancer care.” She stated that because so many patients with cancer are on a mix of drugs, “if some of those drugs could be biosimilars and reduce the cost burden to both the patient and to the system, I think we could be able to afford, as a nation, to make more progress.”

Fildes announced that ERISA will unveil new research on savings opportunities regarding biosimilars for patients and employers on March 31. “There are perverse incentives for providers and for hospital systems, and there is a complete and total lack of transparency in the drug supply chain. Employers need to know about the cost of drugs,” she said.

She also called on Congress to do something about rebate systems, unclear pricing, and patent thickets that are often blamed for sluggish biosimilar uptake in the US market. “This administration can and must take action to break through the gridlock in Congress and bolster the biosimilars marketplace, because when it does, seniors and taxpayers win,” she said.

Awsare stressed that overcoming hurdles facing biosimilar development in the United States in order to help patients is only going to happen by “really working together…across patients, physicians, the FDA… to say these things are safe and available.” She added, “Let’s do it for our patients.”