As politicians and policymakers debate effective ways to rein in rising health care costs, biosimilars represent an obvious solution for saving billions of dollars a year. These products offer the same safety and effectiveness as the reference biologics they are designed to match. So why aren’t they being embraced by patients, physicians, and payers?
Blame that in part on misinformation about these products — some of it coming from the pharmaceutical industry — and the lack of market preparation to support the uptake of biosimilars in the U.S.
Biosimilars offer the health care system more affordable options than their biologic reference products while meeting the same rigorous standards for safety, purity, potency, and effectiveness. The RAND Corporation has estimated that a flourishing biosimilars market could save the U.S. as much as $54 billion over the next decade.
Yet even though the Biologics Price Competition and Innovation Act was signed into law in March 2010, paving the way for the introduction of biosimilars into the U.S. marketplace, only 20 have been approved in the U.S. Just seven of them are now being marketed, and most are struggling to gain a fair market share. Misinformation accounts for some of the lack of uptake.
Some biologics manufacturers and groups have issued misleading, incomplete, and inaccurate information about the safety and effectiveness of biosimilars in an attempt to slow acceptance of and access to biosimilars. This mischaracterization is pervasive and threatens to stall system-wide health care cost savings and the advancement of biosimilars in the U.S. with untoward fear mongering.
Pfizer’s August 2018 citizen petition asking the Food and Drug Administration to issue guidance for biosimilars communications cites a few instances of misinformation. The petition states that “the textual summary comparing biosimilars and generics on Genentech’s Examine Biosimilars website explains that ‘the FDA requires a biosimilar to be highly similar, but not identical to the [reference product]’ but fails to state that an approved biosimilar must have no clinically meaningful differences from the reference product.” The website also failed to mention that batch-to-batch variability for biosimilars is permissible — and is routine for reference products.
Former FDA Commissioner Scott Gottlieb acknowledged that misinformation is a problem. In an interview with the Washington Post two months before leaving the FDA, Gottlieb said, “I am worried that there are either deliberate or unintentional efforts by branded companies to create confusion” about the safety and effectiveness of biosimilars. These messages, he added, “can potentially undermine consumer confidence in biosimilars in ways that are untrue … [and] negatively impact a patient’s judgment about an otherwise safe and effective product.”
Although Gottlieb did not name any specific companies or groups in the interview, the Post article went on to say that an alliance of biologics manufacturers has issued inflammatory warnings about biosimilars such as “you could end up in the emergency room,” and “they may or may not produce the same effects, or they may carry additional risks.”
Pfizer’s citizen petition cites specific efforts to mislead patients about the safety and efficacy of biosimilars. For example, Janssen’s patient brochure for Remicade emphasizes that a biosimilar, Inflectra, is not interchangeable and implies that it may not be as safe or have the same results. A YouTube video from Amgen implies that switching to a biosimilar is unsafe. None of these insinuations about safety or clinical performance are true and, in fact, directly undermine efforts to promote the acceptance of biosimilars.
Misinformation doesn’t come only in the form of misleading information. It can also consist of omitting essential information. Both types are notable in recent efforts to disparage the value of safety monitoring programs in Europe. Such efforts are particularly insidious because the strong safety record of biosimilars in the 13 years since these products first became available in Europe is a very strong point supporting their safety. Since the first biosimilar was launched in Europe in 2006, there have been more than 700 million patient days of exposure to biosimilars and no new safety concerns have emerged that were not previously observed with the reference product, according to the European Medicines Agency.
Despite these facts, the validity of European safety data for biosimilars has been under attack. In a panel presentation hosted by The Atlantic on June 1, 2018, and again at an FDA hearing held on Sept. 4, 2018, Andrew Spiegel, executive director of the Global Colon Cancer Association, stated that safety monitoring of EU-approved biosimilars was “not adequate” and that it was a “missed opportunity.”
There are ongoing efforts to suggest significant weaknesses in European safety reporting. In a STAT First Opinion, a claim was made that in a single recent year 26% of infliximab safety reports in Europe did not include brand names and therefore could not be properly tracked. The article and the publication it cites failed to reveal that brand names are only one of several elements used to identify products in safety reports. Nor is there mention of any of the other 14 biological molecules for which biosimilars are marketed in Europe. Several prominent European health authority experts and academics on biosimilars have published data showing that over a recent five-year period “adequate identifiers were reported for 96.7% of suspected biologicals.”
To overcome ongoing misinformation efforts directed against biosimilars and to help support acceptance of biosimilars in the U.S., strong education must be provided to patients, providers, and the broader health care industry that the FDA has concluded that biosimilars are just as safe and effective as their reference products.
The U.S. has a real opportunity to push back on misinformation. This will help foster a fair, competitive, and robust biosimilars marketplace that can help unlock major, much-needed cost reductions.
For more than a decade, biosimilars have flourished in the European Union, creating a competitive, multi-source biosimilars market that both increases patient access and saves money. That hasn’t happened here because the U.S. market hasn’t been prepared for them.
A March 2019 report by the Biosimilars Forum and Medicines for Europe analyzed the EU experience. It found that biosimilars were as safe and effective as their reference products and identified how the EU prepared for biosimilars to reach the market. For example, the EU has a clear, centralized pathway for approving and switching to biosimilars, requires only one signature from a physician to prescribe a biosimilar, and enacted policies — such as the September 2017 framework from the United Kingdom’s National Health Service — to help the industry prepare for biosimilars. These tactics have helped create a more seamless and competitive landscape that led to increased understanding of these medications by physicians, which increased uptake and allowed more patients to access biologic treatments.
The U.S. can and should do the same.
For example, the Department of Health and Human Services, the Centers for Medicare and Medicaid Services, the Department of Veterans Affairs, private insurers, and other payers should create incentives across all stakeholders to drive biosimilar utilization. No copays or preferential cost-share policies can, for example, create true patient incentives to use biosimilars in the same ways these policies did for generics. Policymakers should also consider developing enhanced reimbursement or shared-savings models to create physician incentives to use biosimilars.
Policymakers should ban policies requiring patients to receive the originator biologic before a biosimilar can be prescribed, also known as fail-first policies. Such policies are not scientifically appropriate and effectively permanently block access to a biosimilar, because patients who stop responding to a reference product will also fail to respond to the corresponding biosimilar. Patients should not be forced into taking a more expensive biologic and should instead be given the opportunity to take the cheaper biosimilar version from the start of their treatment. That way, even if a patient does fail on the biosimilar, he or she did not have to pay as hefty of a price tag by taking the originator biologic. It would allow the system as a whole to save money from the onset.
Fail-first policies are contrary to the ethical practice of medicine and create dangers for patients by delaying appropriate treatments.
Policymakers should also consider how tracking the rate of biosimilar use across payers and plans can help create transparency and guide incentives to drive biosimilar uptake.
We cannot miss our chance to create a thriving biosimilars market that can truly reduce our nation’s health care costs, but it will require the U.S. to act and to act now.
Hillel P. Cohen is executive director of scientific affairs at Sandoz Biopharmaceuticals. Dorothy McCabe is executive director of specialty medicine at Boehringer Ingelheim. They are co-chairs of the Biosimilars Forum Education Committee. The views expressed here are those of the authors in their roles with the Biosimilars Forum, not of their respective companies.
Editor’s note: The sixth paragraph of the article was updated to clarify its description of the Pfizer citizen petition.