WASHINGTON, D.C. — In response to today’s announcement from the Food and Drug Administration (FDA) on new draft guidance to accelerate biosimilar approvals, Patients For Affordable Drugs Now executive director Merith Basey released the following statement:
“We welcome the administration’s commitment to increasing biosimilar competition to lower drug prices for American patients. Expediting the biosimilar approval process – by cutting unnecessary red tape and streamlining duplicative clinical trials – will help speed lower-cost treatments to market for diseases like cancer, arthritis, and autoimmune conditions, delivering relief to patients who’ve waited too long for more affordable options.”
“To build on this effort, Congress must tackle the patent abuses that allow big drug companies to block competition even after FDA approval. Bipartisan patent reform measures currently in Congress would crack down on these patent abuses and close regulatory loopholes. Together, these actions can help restore fairness and accountability to a system that has favored pharmaceutical monopoly power for too long.”
The FDA’s new draft guidance would streamline the process for approving biosimilars, which are more affordable than their biologic reference products. The proposal would remove unnecessary human trials, known as interchangeability studies, when advanced testing already shows that a biosimilar works the same as the brand-name drug and would make it easier for doctors and pharmacists to substitute lower-cost biosimilars, much like generic drugs.
In announcing the new draft guidance, Health and Human Services Secretary Robert F. Kennedy Jr. underscored the human cost of high drug prices and the role pharmaceutical lobbying played in maintaining monopolies: “Across our country, millions of Americans struggle to afford essential medicines. Families are rationing prescriptions, seniors are skipping doses, and parents are facing heartbreaking choices,” he later added that “when Congress wrote the Biologics Price Competition and Innovation Act, the pharmaceutical industry rigged the rules…They claimed that biologics were too delicate, that they were too mystical to allow true generics… it was all clever marketing, none of it was based on science. Then, to block pharmacists and doctors from switching patients to lower-cost options, the lobby invented a fake distinction between biosimilars and interchangeable biosimilars. The result has been sky-high costs, endless red tape, and a biosimilar market that still lags far behind Europe’s.”
FDA commissioner Dr. Marty Makary also highlighted how biologics are driving drug spending and stressed the importance of accelerating competition: “We can create more intense competition and let market forces do their work. When Humira had its biosimilar come out seven years later, it should have been closer to two years — or even one year, as we often see in Europe. When there’s that kind of gap, it means a longer period with no competition and higher prices. We want to see more competition, and we want to see more innovation
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Patients For Affordable Drugs Now is the only national, patient advocacy organization focused exclusively on policies to lower drug prices. We empower and mobilize patients and allies, hold accountable those in power, and fight to shape and achieve system-changing policies that make prescription drugs affordable for all people in the United States. P4ADNow is bipartisan and does not accept funding from organizations that profit from the development or distribution of prescription drugs. To learn more, visit: PatientsForAffordableDrugsNOW.org