It would be difficult today to find someone who feels that America’s health care system is on solid footing. The cost of care is rising, access to needed treatments is being blocked by a system focused on profits over patients, and research funding continues to be cut. According to a recent KFF.org poll, just under half of U.S. adults say it is difficult to afford health care costs, and one in four say they or a family member in their household had problems paying for health care in the past 12 months.
Fortunately, there are still important reforms happening that will support consumers’ access to quality and affordable care that many may not even be aware of. Recently, the U.S. Food and Drug Administration (FDA), under the leadership of Dr. Marty Makary, announced steps being taken to streamline the development of biosimilar medicines to treat some of the toughest diseases at a lower cost than the more expensive biologics so many of us rely on today.
Specifically, the FDA proposed major updates to biosimilarity studies with an aim to “reduce unnecessary clinical testing” and “make it easier for biosimilars to be developed as interchangeable with brand-name biologics.” This red tape cutting measure will bring biosimilars, often referred to as the “generic” versions of biologic drugs, to market more quickly and stands to save consumers and the American health care system billions annually. Today, biologic drugs make up nearly 51 percent of total drug spending, despite representing only 5 percent of prescriptions.
Biosimilars are often thought of as “generic” versions of biologic drugs and aim to cost the average consumer less. Though they take longer to produce than their small molecule “generic” counterparts, the U.S. healthcare system has accrued $56 billion in savings from biosimilars. With more availability, the next five years could result in an increase in savings up to $181 billion. For years, biosimilars have been required to go through rigorous additional testing that is unnecessary and as a result, delays access for consumers. The average American will now be able to more easily gain access to these more cost-effective medications without sacrificing their safety.
As a consumer group with a longstanding focus on the safe use of medications, the National Consumers League takes very seriously the FDA's role in ensuring that all approved drugs are safe and effective. The FDA is the gold standard for safety, and we believe the approval of biosimilars in a more streamlined fashion outlined in this new policy directive will not shortchange safety or put patients at risk in any way. These changes are sensible and more efficient, and above all, protect patient safety.
Biosimilars have long been accepted as a safe and effective alternative to biologics, but outdated regulatory frameworks have significantly slowed the introduction of more biosimilars to the market. With this bold step by the FDA, the American consumer will have increased access to affordable, quality medication for chronic illnesses and serious diseases. We are looking forward to seeing more steps like this in the future.
Sally Greenberg is Chief Executive Officer of the National Consumers League.
