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Samsung Bioepis White Paper Describes Biosimilar Barriers to Adoption


Stakeholder education programs and robust data on clinical studies are key to building patient and provider support for biosimilars, according to a new whitepaper.

A new whitepaper from Samsung Bioepis and Organon takes aim at misconceptions about biosimilars and industry practices that hinder their adoption. The companies held 3 virtual panel sessions with doctors, nurses, pharmacists, policy experts, and patient advocates.

Authors of the paper hold up Cleveland Clinic as a model of a health system that has achieved success in converting patients to biosimilars from reference products.

Key to the success of Cleveland Clinic's program, the authors explain, was educating stakeholders and setting up direct communications so that patients and providers could learn what they needed to know about biosimilars.

Some of those stakeholders were nurses, who were given specific training so that they could “reassure patients about the quality of care they would be receiving and answer any questions patients might have.”

In the broader health care community, “many physicians still lack confidence in biosimilars,” the authors wrote. In oncology, biosimilars have been embraced by physicians and patients, but in gastroenterology, there are lingering concerns about whether these agents will serve patients as well as their reference products.

“Many gastroenterologists who prescribe biologics for their patients with inflammatory bowel disease are concerned about biosimilar safety, immunogenicity, and indication extrapolation,” the authors wrote.

Kaiser Permanente

Another health care institution that has successfully transitioned patients to biosimilars is Kaiser Permanente, authors of the whitepaper said.

“Kaiser’s approach starts with a rigorous review of available biosimilar evidence, including data from manufacturers, FDA approvals, and real-world data from countries where biosimilars have already launched,” they wrote.

Kaiser Permanente got biosimilars into circulation by building physician confidence, a strategy that a Samsung Bioepis executive says should be employed more widely.

Having these data on hand is critical to informing physicians and other stakeholders so they can more readily embrace biosimilars, the authors wrote.

However, those informational materials need to be digestible. “A gastroenterologist participating on the panel who has published on the merits of biosimilars in treating inflammatory conditions shared that many physicians are too busy to study in-depth clinical trial data and would prefer to receive easily digestible educational materials demonstrating a biosimilar’s safety, equivalence, and cost savings,” the authors wrote.

Samsung Bioepis has developed and gained regulatory approval for multiple biosimilar versions of reference products, and it relies on Organon for assistance with marketing these products. Some of Samsung Bioepis’ biosimilars include etanercept (autoimmune), infliximab (immunosuppressive), adalimumab (autoimmune), and other products. The company has a robust pipeline of biosimilars in development, including aflibercept (ophthalmology), denosumab (endocrinology), ustekinumab (immunology), and eculizumab (hematology) candidates.

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