Biosimilar developers can assuage some physician—and even patient—concerns through coordinated, evidence-based messaging.
As patients save money by using biosimilars, there could be greater access to biologic treatments for patients in need, according to a paper published in the journal Drugs. Additionally, the authors suggested, physicians should improve their understanding of biosimilars so they feel more comfortable prescribing them.
A multinational team of investigators outlined their perspective on biosimilars across a wide swath of diseases in order to discuss obstacles to widespread uptake of biosimilars as well as ensure that benefits of biosimilars are maximized for health care systems as well as patients. They estimated that 240 biosimilar candidates are in development for all diseases and noted that several biosimilars have been approved by the FDA and European regulatory agencies (EMA).
However, patients are still treated with the reference products, or the originator biologic, due to physician and patient concerns about biosimilars, the authors said.
From the perspective of regulators and pharmacologists, there has been rigorous and efficient development for biosimilars, the authors wrote. These biosimilars must essentially be “reverse engineered” from the reference product, as the details are not publicly available. The FDA and EMA recommend a step-wise approach to demonstrate biosimilarity, but current investigational techniques are lacking. For example, when testing a biosimilar, investigators must ensure that the intervention population would be sensitive to any differences between the drugs.
Using the example of rheumatoid arthritis (RA), the authors noted that biosimilars have transformed the treatment of the disease. Current guidelines have expanded and recommend access to biologics based on disease duration, disease severity, and number of insufficient responses to synthetic disease-modifying antirheumatic drugs (DMARDs), the authors wrote. But cost can bar patients from seeking biologics; biosimilars have the opportunity to be a more cost-effective treatment.
This “should help to address the disparities in patient access imposed by stringent national reimbursement criteria that may diverge from clinical guidelines,” the authors said.
Biologic use in gastroenterology, especially in irritable bowel disease (IBD), is recommended for certain patients, especially those with severely active disease. The first biosimilars were licensed for IBD in 2013, the authors said, and more have been approved since. All 3 adalimumab biosimilars have shown pharmacokinetic similarity to the reference product in studies of health subjects, as well as similar safety and efficacy levels in clinical trials in patients with rheumatoid arthritis, the authors noted.
But the cost is often prohibitive for patients seeking biologics, the authors wrote. For RA in particular, biosimilars, market competition, and price reductions improve the cost-effectiveness of biologic therapy. Data also supports similar trends for IBD biosimilars, the authors said.
Biosimilars can improve workforce productivity for RA patients, the authors said. That’s not often included in cost-effectiveness analyses, but should be, they suggested. They also wrote that the UK National Health Service saved £324 (US$350) million in the 2017-2018 financial year by switching to biosimilars or generics for 10 medicines. Nearly £100 million was saved through use of infliximab biosimilars, they added.
How do patients feel about biosimilars? The authors said that patient health literacy may play a role, but some advocates believe that patients should be fully informed and allowed to make evidence-based choices about their care. It’s important to note that a patient may experience a “nocebo” effect—the worsening of symptoms induced by a negative attitude about an intervention—which can impact quality of life, treatment adherence, and the cost-saving potential of the biosimilar, the authors said.
“Positive framing, contextualized informed consent, and unified communications can also reduce nocebo effects,” the authors said. “Despite the increasing use of internet health information by patients, one survey found that perceived physician quality had a greater impact on treatment compliance than the perceived quality of internet health information, emphasizing the importance of health care professional communication.”
Developers can also help bring biosimilars to the forefront by coordinating messaging through respected journals to reach physicians. Biosimilars can also find support through the conducting of additional analyses of clinical data that reflect recommendations from medical societies, the authors said.
With the creation and release of more biosimilars, competition will drive prices down. The developers and payers should align pricing and market access to support a thriving biosimilar market, the authors said.
“All stakeholders must collaborate efficiently to realize the ultimate goal of biosimilar development: delivering the clinical benefits of biologic therapy to patients without sacrificing the sustainability of the healthcare system,” the authors concluded.
Kim H, Alten R, Avedano L, et al. The future of biosimilars: maximizing benefits across immune-mediated inflammatory diseases. Drugs. 2020; 80;99—113 doi:10.1007/s40265-020-01256-5.