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When It Comes to Instilling Confidence, What's Said About Biosimilars Matters


“Talk about the success first,” said Steinar Madsen, MD, medical director of the Norwegian Medicines Agency. “Forget the nonexistent problems.”

During the SMi 10th Annual Biosimilars Conference, Stephen Murby, a board member of the Alliance for Safe Biological Medicines (a group that counts innovator biologic group Biotechnology Innovation Organization among its membership, along with patient organizations and medical societies), took issue with what he sees as a trend toward payer-driven initiatives to increase biosimilar adoption, and his discussion raised concerns about how stakeholders communicate about biosimilars.

Murby referred to British Columbia’s recent decision to transition patients who use PharmaCare, a publicly funded drug coverage program, from reference anti—tumor necrosis factor therapies and insulins to biosimilar options. The program has allowed budget for the province to cover additional high-cost therapies, including empagliflozin (Jardiance) and ixekizumab (Taltz). However, some patient organizations, including Crohn’s and Colitis Canada, have voiced concern about the mandated switch.

“This is a push,” said Murby, adding that his organization’s provider surveys from 2014 and 2017 show that Canadian providers want a say in whether to switch to a biosimilar.

Murby also criticized payer-led initiatives in Australia, where, he said, the decision to allow pharmacy-level substitution of some biosimilars (those given “a-flag” designations on the Pharmaceutical Benefits Scheme) for their reference products was met by an informal alliance of prescribers and pharmacists who agreed not to substitute products in routine practice. The authorities “could have made their lives easier if they just spoke to patient and prescriber groups,” said Murby.

When an audience member challenged Murby to consider the fact that large studies of patients involved in nonmedical switches, such as DANBIO and NOR-SWITCH, have not raised concerns about the safety and efficacy of switching to biosimilars, Murby said that he considered patients enrolled in such studies to be a “living laboratory,” and stated that he believes it will take another 10 years before data from these studies will be conclusive. “I don’t want to be somebody’s lab rat,” Murby said.

Speaking from the audience during a question-and-answer session, Rodeina Challand, of Challand Biosimilar Consulting, cautioned that the language used to speak about biosimilars in highly regulated territories like Europe, the United States, Canada, and Australia can have a direct impact on patients in emerging markets. In low-resource countries where biosimilars may be the only options for patients to receive therapy, physicians look closely at what their peers in other nations have to say about these products. Needlessly casting doubt on biosimilars, she said, can mean that providers are reluctant to prescribe these life-changing and life-saving therapies.

In his own presentation the following day, Steinar Madsen, MD, FACP(Hon), medical director of the Norwegian Medicines Agency, which conducted the NOR-SWITCH trial, also took aim at negative comments on biosimilars, and urged attendees to remember that “we are at a critical moment in the history of biosimilars just now. We are here to save money and treat more patients.”

While Norway has put in place important mechanisms to promote the use of biosimilars, practices like automatic substitution are just one set of tools. It’s important, Madsen emphasized, “to talk well about biosimilars.”

“In every conference, there is endless discussion about comparability exercises, etc, etc. Is that interesting anymore?” Madsen urged attendees to remember that biosimilar switching in Nordic countries, where patients may switch multiple times among reference and biosimilar products, is “very efficient, very safe, and works very well,” and asked them to look at successes with biosimilars rather than discussing theoretical problems.

He also suggested that there is a double standard when it comes to discussing biosimilars and reference products with respect to product quality, alluding to a case in which a shift in antibody-dependent cell-mediated cytotoxicity in brand-name trastuzumab, Herceptin, was linked with reduced event-free survival in patients with breast cancer. Despite the fact that this shift came to light only because biosimilar developers identified the change to this critical quality attribute in the reference trastuzumab, “it’s always the generic or the biosimilar that gets the blame,” said Madsen.

He went on to urge stakeholders to avoid what he referred to as “nocebo talking,” or discussing biosimilars in such a way that needlessly generates mistrust in biosimilars among patients that can have a negative impact on their treatment outcomes.

“Talk about the success first,” he said. “Forget the nonexistent problems.”

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