FDA Support for 'Biosimilars' Will Reduce Drug Costs
As part of efforts by the White House to curb prescription drug spending in the United States, the Food and Drug Administration (FDA) recently unveiled a new plan to support groundbreaking drugs known as biosimilars. Researchers across the country continue making exciting breakthroughs in the development of these innovative therapies, which treat many patients suffering from cancer, rheumatoid arthritis and other chronic diseases.
While other elements of the administration’s drug spending plan may have received more immediate attention, the FDA’s new Biosimilar Action Plan has the potential for long-term transformation of the nation’s health-care system by spurring competition and making treatments more accessible for millions of American patients.
Biosimilars provide a safe and effective way to help reduce health spending nationwide. As a result, they have been made a priority by the FDA. Biosimilar drugs are highly similar to a biologic drug that has already been developed. That means that patients and their health-care professionals can expect the same clinical results from using a biosimilar, even though it is less expensive to develop. In fact, biosimilars are expected to reduce health spending by as much as $54 billion in the next decade.
The Biosimilars Action Plan promises to encourage the development of a more vibrant biosimilars market in the United States by improving the efficiency of the approval process. For example, the FDA detailed plans for developing and implementing new review tools, including a standardized review template. This encouraging step will reward innovation and foster a more competitive market by making the approval pathway easier to navigate.
The FDA also sought to improve clarity among biosimilar developers by improving coordination of its guidance documents and harmonizing international regulation of biosimilars. This will help the U.S. take advantage of expertise in Europe, where biosimilars already play a significant role in patient care. In fact, European countries have already seen more than 700 million patient days of clinical experience and evidence demonstrating the quality of biosimilar treatments.
By strengthening partnerships with regulatory agencies in these countries, the FDA will help to level the playing field for biosimilar developers in the U.S. and usher in the next wave of high quality biosimilar products.
Perhaps most importantly, the Action Plan stressed the importance of educating patients and physicians about biosimilars as a key driver to increasing use of these drugs in the U.S., where awareness significantly lags. The FDA outlined plans for developing audience-appropriate educational materials such as videos and informational guidelines to explain key concepts about biosimilar drugs. These efforts will dovetail with the FDA’s recent education and outreach campaign and help break down barriers preventing greater use of these treatments.
Supporting the growth of biosimilars must be a critical component of any effort to lower drug costs for Americans. In releasing the Biosimilars Action Plan, FDA Commissioner Scott Gottlieb has demonstrated a strong commitment to the development of a robust biosimilars market in the U.S.
In the months ahead, the FDA will need to work with diverse patient advocacy communities as well as the entire medical community — prescribers, pharmacists, payers, and developers — to realize the plan’s potential. Together, we can advance the use of biosimilars nationwide and improve access and affordability for all patients.
Juliana M. Reed is president of the Biosimilars Forum, a nonprofit organization whose mission is to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines and improving health care.