Biosimilars Month in Review: December 2023

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The biosimilars month in review highlights interviews with clinicians discussing the cost-saving potential of increased biosimilars uptake in the US, the recent US Food and Drug Administration (FDA) approval of bevacizumab-tnjn, and the impact of a mandatory switch to an adalimumab biosimilar in New Zealand.

According to experts, the focus lies on understanding the barriers obstructing smoother transitions and higher uptake of biosimilars, emphasizing the importance of addressing issues related to patient satisfaction, pricing, and support structures to improve overall adoption rates.

Challenges of Biosimilars Adoption in the US

Although the extent of coverage and accessibility relies on a patient’s specific health insurance plan, biosimilars foster pre-market competition and offer a broader array of treatment choices, often at a considerable discount compared to the reference biologic. This month features interviews with experts weighing in on the crucial role biosimilars play in healthcare, as well as the barriers to access and adoption.

Breaking Down Barriers: Why Biosimilars Face Resistance in the US Market

Despite the influx of biosimilars approved in the US in recent years, the adoption of biosimilars has been unexpectedly slow. Factors including interchangeability designation, pharmacy benefit managers (PBMs) limiting access to the drugs, and a lack of knowledge and comfortability with biosimilars among providers and patients have made it difficult for biosimilars to flourish in the US market the way they have in many other parts of the world.

Russell D Cohen, MD: Understanding the Role of Biosimilars in Healthcare

In an interview with Cohen, a gastroenterologist and professor at the University of Chicago Medicine, he discussed the value of the introduction and expansion of approved biosimilars in the US and eased potential concerns clinicians may have when debating to prescribe a biosimilar to their patients.

“Many experts would agree that there is significant potential for competition from biosimilars to improve access and drive down costs – something that generics achieved for the US health care system in the 20th century,” he said. “As a doctor, I think the potential opportunity for biosimilar adoption to expand choice, access, and affordability of biologic medicines is important.”

Juliana Reed, MS: The Crucial Role of Biosimilars in Encouraging Competition, Lowering Costs

Reed explained while there are currently 8 adalimumab (HUMIRA) biosimilars available, these biosimilars face obstacles in reaching the market and achieving uptake. Unfortunately, she said, PBMs are impeding access to these adalimumab biosimilars, which hinders the potential cost savings and competition these biosimilars could deliver.

“It’s a very expensive medicine, [and if patients] had access to the adalimumab biosimilars they could be saving 85%,” she said. “So, that is a significant clinical problem because not being able to have your medicine and save money at the same time creates fiscal hardship on the patients and their families who have to pay these high costs.”

New FDA Approval of Additional Bevacizumab Biosimilar

FDA Approves Bevacizumab Biosimilar Bevacizumab-tnjn for Lung, Colorectal Cancers

In early December, the FDA approved Bio-Thera Solutions’ bevacizumab (Avastin) biosimilar, bevacizumab-tnjn (Avzivi), for the treatment of lung and colorectal cancers. The decision marked Bio-Thera Solutions’ second FDA-approved product in the US.

The drug, a humanized monoclonal antibody, targets and binds to vascular endothelial growth factor (VEGF) to reduce neovascularization, thus inhibiting tumor growth.

“The approval of Avzivi by the FDA will provide lung and colorectal cancer patients a new cost-effective treatment option,” professor Li Zhang, lead investigator of the global phase 3 study, said in a statement. “We hope Bio-Thera continues to make more high-quality biosimilars available to patients around the world."

Insights on Biosimilar Adoption

This month’s coverage also focused on biosimilar usage and transitions. While one study revealed higher uptake in Medicare Advantage and the need to investigate factors influencing these differences, a second study examined the mandatory switch to an adalimumab biosimilar in New Zealand. Results demonstrated patient dissatisfaction, citing issues with support, supplies, and perceived quality. Both emphasize the significance of understanding and possibly improving biosimilar adoption.

Biosimilar Market Share Greater in Medicare Advantage Versus Part B

Analysis from a team of federal agency and pharmaceutical industry-based investigators showed biosimilar uptake was, in the cases of some observed products on the market, up to 2-fold greater in Medicare Advantage coverage than traditional Medicare. The new data supplement prior findings showing significant differences in biosimilar use between managed care versus fee-for-service Medicaid, suggesting a need to investigate the various mechanism that which may inform the discrepancy in market share for cost-efficient biosimilars.

The team concluded that biosimilar market share was suggestive of greater frequency in Medicare Advantage versus traditional Medicare, consistent with other observed findings.

“One suggested explanation was differential statutory state inflation rebates in managed care vs fee-for-service payers. Implementing the Medicare inflationary rebate may also affect Medicare Advantage and traditional Medicare biosimilar uptake,” wrote lead investigator Yoganand Chillarige, MPA, of Acumen LLC, and colleagues.

Patients Unsatisfied After Mandatory Adalimumab Biosimilar Transition

A team of investigators led by Chiara Gasteiger, PhD, from the University of Auckland, New Zealand, sent online surveys to patients switching from the originator adalimumab to the biosimilar. Ultimately, they wanted to see if patients were satisfied or unsatisfied with the transition, including areas such as care supplies, administrative burdens, information and education, and availability of support.

With the transition, participants rated their overall mean satisfaction as a 6.2. They were unsatisfied with the support and information received from support organizations, as well as the training for the biosimilar device. Moreover, patients were unsatisfied with the provision of sharp bins (P <.001) and alcohol wipes (P <.001).

“While participants appreciated less injection pain and the ease of the biosimilar device, overall satisfaction with the transition was low,” investigators concluded. “Patients’ experiences can be improved by providing alcohol wipes, sharps bins, and a comparable patient support program.”