Biosimilar medications are highly similar — and have no clinically meaningful difference in terms of safety and effectiveness — to Food and Drug Administration-approved originator biologic medications. Biosimilars are safe and often lower-cost versions of their originator biologic drugs that must meet the same rigorous FDA standards for safety, purity, potency and effectiveness. Currently, biosimilars on the market cost nearly 30 percent less than their originator products and could save the United States as much as $54 billion over the next decade.
However, despite studies and real-world evidence demonstrating the cost-effectiveness of biosimilars, biosimilars are not yet readily available in the United States. As of this year, the FDA has approved 23 biosimilars.
The lack of access to cost-effective biosimilars is due to a variety of factors, including misinformation about the efficacy of biosimilars, efforts by some manufacturers to extend their own patent protections, and rebates granted by some manufacturers to insurers and pharmacy benefit managers to cover biologics and not biosimilars.
Patients need policies that curb anti-competitive behavior by some manufacturers and increase access to biologic medications and competition in the marketplace. Increased access cannot be accomplished without common-sense action by Congress.
Two solutions that may help reduce costs and increase access to biosimilars are reducing out-of-pocket costs for biosimilars and developing a shared-savings model for health care providers.
Reducing or eliminating patient out-of-pocket costs for biosimilars would increase adherence, which would provide substantial overall savings for patients — saving seniors as much as $3.3 billion and the health care system up to $5.2 billion over the next 10 years.
A shared-savings model would incentivize providers to prescribe biosimilars by sharing with the providers the Medicare cost savings associated with prescribing a biosimilar instead of an originator biologic product. A recent policy analysis estimated a cost savings of $3 billion saved over the next 10 years if the United States were to implement a biosimilar shared savings program for Medicare Part B providers.
As a national patient advocacy organization representing thousands of men and women suffering from chronic conditions, we support public policy that increases access to affordable treatments. When physicians have the option of prescribing safe, effective and lower-cost versions of life-saving generic drugs, they will be able to create real value for patients.
It is far past time for Congress to give patients meaningful relief from rising prescription drug costs. We urge Congress to act now to unlock the cost-savings potential of life-saving biosimilar medications.
Liz Helms is co-founder of the Chronic Care Policy Alliance, a multi-state advocacy group working to further policy initiatives that support access and affordability to treatments for patients with chronic conditions.