Prioritize Patient Treatment Stability, Physician Confidence
Michael Reilly
September 25, 2024
Biologic medicines have revolutionized the treatment of serious chronic diseases including, arthritis, psoriasis, Crohn’s disease, and cancer. Nearly 10 years ago, the FDA approved the first “biosimilar” – a copycat medicine highly similar, but not identical to a previously-approved biologic. Biosimilars offer new treatment choices and more price competition, increasing access and affordability for patients. To date, 59 biosimilars have been approved and have saved our health system $24 billion. The FDA’s approval standards have rightly earned physician and patient trust. Unfortunately, Congress is now considering weakening those standards – which could inadvertently jeopardize the health of millions of patients and with it, confidence in these medicines.
While safe and effective, biosimilars aren’t generics because they aren’t identical copies of a biologic. Insurance companies and pharmacy benefit managers (PBMs) cannot treat biosimilars like generics and simply switch a patient to their preferred version, usually the more profitable medication. Under state law in all 50 states, only “interchangeable” biosimilars may be substituted by a third-party without prescriber approval. Interchangeables have demonstrated to the FDA through data, including switching studies, that a patient can expect the same results with no additional risks, even after multiple switches, compared to a patient who remained on the original biologic.
Surveys show nearly all physicians – 89% – are confident in biosimilars. Nevertheless, 69% believe that patients and physicians should control the decision to switch medications, not insurers and pharmacists. That’s because treatment plans aren’t universal; they are as individual as patients themselves. Patients often try several different medicines before finding the one that works best to treat their condition. An interchangeable designation makes almost 60% of physicians more comfortable with a biosimilar substitution at the pharmacy, knowing a stable patient won’t be put at risk by third party-switching.
State medical societies nationwide support the laws now permitting the substitution of interchangeable biosimilars. However, that support was conditional on assurances from policymakers that third-party substitution would be limited only to interchangeable biosimilars backed by additional safety and efficacy data.
But the safeguards physicians count on may soon be removed. This week, the Senate HELP Committee, which includes my own senator, Tim Kaine of Virginia, will vote on a bill that would classify all biosimilars as interchangeable. It would permit insurance companies to switch patients to any biosimilar as if they were generics, removing prior physician approval, in absence of now-required data demonstrating that switching won’t reduce safety and efficacy. The Biosimilar Red Tape Elimination Act would also remove the FDA’s ability to ask for switching studies when appropriate, dangerously lowering current safety standards. If this bill becomes law, it could negatively impact treatment stability for millions of patients.
Both policies are strongly opposed by the clinicians who best understand these medicines. A recent survey of 270 physicians who prescribe biologics revealed that a mere 11% believe all biosimilars should be classified as interchangeable, and 88% said biosimilar switching studies increase their confidence in safe switching.
Congress has a responsibility to retain the rigorous standards for interchangeability that have kept U.S. patients safe, earned the trust of physicians, and lowered health care costs. A failure to do so will put patient health outcomes, and physician trust in these important medicines, in jeopardy.
Michael Reilly served in the Office of the Secretary of the U.S. Department of Health and Human Services from 2002-2008, including three years as Associate Deputy Secretary. He serves as Executive Director of the Alliance for Biologic Medicines and resides in Alexandria, VA.
