The Biggest Obstacle to Cancer Biosimilar Development

As costs continue to skyrocket, the healthcare industry is looking for ways to contain spending, without sacrificing the quality of patient care in the process. Biosimilars, or products that are considered highly similar to (and therefore as clinically effective as) biologic drugs, offer one way to better manage costs. In fact, the RAND corporation estimates that biosimilars could result in savings of over $50 billion dollars by 2026.

This kind of cost containment is particular attractive to the field of oncology due to the high costs of biologic therapies. Gary H. Lyman, MD, MPH, a former oncologist and senior lead researcher of Health Care Quality and Policy for the Fred Hutchinson Cancer Research Center, says adoption of cancer biosimilars in European markets has been highly encouraging-yet, many challenges remain for development and adoption in the United States.

“At last count, the FDA has approved 17 biosimilar drugs, with eight of them being oncology-related,” he says. “They are starting to be incorporated into treatment guideline recommendations, but it’s a work in process.”

While analysts often discuss obstacles ranging from payer formulary management to the large number of ongoing legal battles, Lyman says the greatest obstacle to development and adoption, from his perspective, is education.

“Most of us working in the oncology field are pretty comfortable with the regulatory processes that have been put in place,” he says. “But what’s missing is data-the kind of data that will help convince physicians and patients that these drugs are equally as effective as what’s currently being used as the backbone of a cancer treatment.”

Related: The State of Biosimilars in 2019

Lyman says that data from Europe suggest that clinicians are more likely to use biosimilar agents in more advanced disease settings, relying on the original biologics in early staged patients. He argues that it’s understandable-it’s hard for physicians to trust the validity of these treatments if they can’t look at the data themselves. And, at this point, the FDA doesn’t require that biosimilar developers do so-drug approval is mostly dependent on preclinical studies instead of phased clinical trials.

“A couple of recent biosimilar approvals have not gone through an oncology drug advisory committee, a review where everything is published in the public domain,” he said. “The FDA has approved the drug. But if the data isn’t there, it’s hard for oncologists to embrace it.”

He recommended that biosimilar manufacturers who have done their due diligence find ways to make development and validation data available. In an article published in the New England Journal of Medicine in May, 2018, entitled, “Rationale, Opportunities, and Reality of Biosimilar Medications,” Lyman and colleagues suggested biosimilar developers can engage with professional associations, legislators, and policy makers to offer more extended training and education about where, when, and how the drugs should be used-and just where they can offer the most savings.

“The education piece is so important. Get the data published. Get it in the peer-reviewed literature so that clinicians, oncologists, and patients can see the data upon which the approval is based,” he says. “This is clearly going to be critical for guideline panels to say, ‘Yes, you should use this,’-it’s effective and can result in savings in the long run.”

This data, Lyman argues, can not only help promote utilization-but also help with other adoption obstacles like payer formulary management and legal contests. And, with time, the market will see multiple biosimilars approved in the same class, resulting in meaningful competition and substantial reductions in price.

“It starts with education,” he says. “But it will end in lowered costs and improved access. As the market grows, we can make sure that patients benefit, both in terms of their disease treatment and their financial well-being.”

Kayt Sukel is a science and health writer based outside Houston.