The Key to Building a Vibrant Biosimilars Marketplace
Despite the enormous promise that biosimilar drugs hold for increasing patient access to care and bringing down costs, surveys show that too many in the medical community are unaware of the benefits they offer. But a new Food and Drug Administration (FDA) awareness campaign aimed at educating doctors, patients and other stakeholders about the safety and effectiveness of these critical, life-saving drugs could be key to building a more robust biosimilars marketplace in the U.S.
Biosimilar drugs are less-expensive versions of “biologic” drugs, which are breakthrough medications that treat patients suffering from cancer, anemia, autoimmune disorders and other chronic conditions. A survey conducted by the Biosimilars Forum in 2016, however, found that many specialty physicians, despite being aware of biosimilars generally, were unaware of the stringent requirements regarding safety and efficacy that they must meet for federal approval.
This knowledge gap has played a significant role in stalling the growth of a vibrant biosimilars market in the U.S. As patients struggle to keep up with rising prescription drug costs and the health care debate continues to reverberate in the halls of Congress, the FDA’s newly launched effort to increase education and awareness is critical to unlocking the benefits of biosimilars for our health care system.
Central to the FDA’s campaign is demonstrating the safety and efficacy of biosimilars. Biosimilars drugs are manufactured in FDA-licensed facilities and are rigorously tested before they can be approved for patient use and deemed as “interchangeable” with their biologic reference drugs. As the FDA notes, “Prescribers and patients should have no concerns about using these medications instead of reference products.” The FDA also makes clear that biosimilars are carefully tracked — in the same way biologics and other drugs are — as part of post-market surveillance.
The FDA’s strict approval pathways for biosimilars also guarantee they are just as effective as biologics. In approving seven biosimilars thus far, the FDA considered the latest clinical research on the purity, molecular structure and bioactivity of the drugs and concluded they had “no clinically meaningful differences in safety, purity, or potency” compared to their biologic counterparts.
The cost savings of widespread use of biosimilars for the American health care system could be significant. A new study released this month by the Rand Corp. found that biosimilars could cut health care spending in the U.S. by $54 billion over the next ten years, as more cost-effective versions of expensive biologic drugs increase access to care for even more patients.
These types of benefits are already being realized throughout Europe, Australia and South Korea, where biosimilars are widely accepted and used by patients. In the United Kingdom, patients have used biosimilars for more than a decade without sacrificing safety or quality; in fact, of the 20 biosimilars products available in the U.K., none have been withdrawn or suspended for safety and efficacy reasons.
Now that the FDA has set in motion a nationwide effort to expand awareness of biosimilars, the medical community can benefit from the agency’s guidance and consider these drugs as viable treatments for patients. For those suffering from life-threatening conditions such as cancer, anemia and autoimmune disorders, these safe, effective and more affordable options for care cannot come fast enough.
Stacie Phan is President of the Biosimilars Forum.