Policy Harmonization, Clarification Could Aid Biosimilar Uptake Efforts

Realigning definitions and policies across regulatory agencies and developing a better understanding of how different stakeholders approach biosimilars could help get more patients and providers on board with using biosimilars, according to panelists at the DIA Biosimilars Conference.

The DIA Biosimilars Conference was held in Arlington, Virginia from September 20-21, 2022, and offered insights into the current challenges of the biosimilar industry and how it’s expected to grow and change in the next few years.

During the session entitled “Flipping the Switch: Building Confidence About Biosimilar Transitions and Substitutions,” Julie Maréchal-Jamil, MSc, director of biosimilar policy and science at Medicines for Europe and a member of The Center for Biosimilars® Advisory Board, shared how regulatory agencies around the world have different definitions of terms related to biologics, such as reference product, interchangeability, and switching, leading to confusion over whether biosimilars are truly as safe as their originators.

“So, what we see is that this misalignment of words, these choices of words in a different context has led to potentially confusion among users….Sometimes when you're not inside the regulator's mind, it's hard to piece together that information…. I think, globally, all the flags are pointing to just more communication between people,” said Maréchal-Jamil.

Thomas Herndon, MD, senior scientific reviewer at the FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB), shared the current literature on switching from a reference product to a biosimilar and expressed that although there isn’t that much currently, more work is being done to show that originator-to-biosimilar switching and biosimilar-to-biosimilar switching are safe for patients.

“Outreach efforts continue, and similar educational approaches to address concerns with switching to biosimilars may also be strategies that are utilized for concerns providers and patients may have with switching over to AES from an originator biologic to a biosimilar in the same drug class,” Herndon expressed.

Sonia T. Oskouei, PharmD, vice president of biosimilars at Cardinal Health and a member of The Center for Biosimilars® Advisory Board, stressed that the adoption experience of some biosimilars cannot be generalized to other disease states, because several aspects can impact willingness to adopt, including:

• Therapeutic area
• Site of care
• Treatment type
• Institution type
• Product type
• Manufacturer commercialization strategies

Oskouei shared data from Cardinal Health’s report published in February 2022 that demonstrated how providers for different diseases disagreed on their views of biosimilars and the possibility of switching to them, showing that providers of all clinical spaces may need more individually tailored biosimilar education.

“As we look at the pipeline of new areas that are going to be experiencing biosimilars and the new stakeholders experiencing it, it's going to be very important in a proactive education effort,” Oskouei said.

Anna Hyde, MA, vice president of advocacy and access at the Arthritis Foundation, touched on the growing concerns among patients and their caregivers, especially as the United States prepares for up to 10 adalimumab biosimilars entering the market in 2023. Patients with chronic diseases may be worried that their prescriptions may change and that new biosimilar products won’t have the same autoinjector devices or be citrate-free like the products they’re used to.

Hyde stressed that clinicians at every level will need to be a part of education efforts to ensure that patients and their caregivers are confident in biosimilars.

Additionally, the FDA has been a part of the research and education efforts for improving perception surrounding biosimilars, including creating new educational materials for patients and conducting surveys, according to Sarah Crowley-Ikenberry, MA, senior communication advisor of the FDA’s OTBB, Office of New Drugs, and Center for Drug Evaluation and Research.

“[Providers] think that having this information will help increase their confidence not only in their prescribing but in their communications with patients, which directly leads to the [prevention of the] nocebo effect…because when doctors come to a patient with hesitancy, when they're uncertain and they don't know about it, that is communicated loudly and clearly, either through body language or direct words, to the patient and may really impact the experience that they may have,” Crowley-Ikenberry explained.

During the conference, several sessions touched on the recent FDA approval for Cimerli as an interchangeable ranibizumab biosimilar despite the fact that Cimerli would be provided under the medical benefit and that interchangeability only impacts pharmacy benefit products, thus raising concerns about whether the FDA is sowing more confusion around what the designation means without realizing.

Crowley-Ikenberry clarified, “There's a lot of misinformation. Some people just think that the FDA makes a determination on our own. Like we get an application package and think, ‘Oh, this looks good for an interchangeable [biosimilar].’ But that's not how it works at all. We don't evaluate an application for interchangeability unless the manufacturer specifically applies as such.”