Six years following its approval of the first biosimilar, the Food and Drug Administration (FDA) has approved the first interchangeable biosimilar, an insulin product for people with diabetes.
This historic approval delivers on the promise of increased savings and competition for extremely costly biologics.
With this designation being the first of its kind, it’s understandable to have questions about these medications. Here are three things to know about interchangeable biosimilars:
1. Interchangeable biosimilars must meet rigorous clinical and regulatory standards.
Biosimilars are highly similar alternatives to biologics that undergo a rigorous evaluation to ensure the efficacy, safety and quality of these products. In addition to meeting the standards of a biosimilar, an interchangeable biosimilar must meet separate regulatory requirements from the FDA. This means the interchangeable biosimilar must produce the same clinical result as the original biologic in any patient. Additionally, a patient must be able to switch back and forth between the interchangeable biosimilar and the original biologic with no safety risks or decreased effectiveness. Only then does the FDA approve the biosimilar as interchangeable.
2. Interchangeable biosimilars can be automatically substituted at the pharmacy.
Because interchangeable biosimilars have met an additional standard, they can be automatically substituted for the original biologic product, subject to state pharmacy practice laws. This process is similar to how generic drugs are routinely substituted for brand name drugs, and doesn’t require consultation with the prescriber. With an automatic substitution, the patient receives a medication that is safe and effective, and often at a lower cost than the original.
3. Interchangeable biosimilars drive down cost of expensive medications by increasing competition.
When it comes to medication, the primary concern is always clinical appropriateness, not drug cost. However, the increase in pharmacy spending, especially for specialty medications, can put these complex treatments out of reach for patients. With interchangeable biosimilars, not only does this bring cost savings for patients using them, but is an important step in creating marketplace competition to lower pharmaceutical costs overall.
As with all drugs that come to market, Express Scripts’ independent Pharmacy and Therapeutics (P&T) Committee completes a thorough review of approved biosimilars to ensure that coverage is based first and foremost on clinical evaluation. No financial discussions or information is shared during the committee’s review. The result? Safe and effective treatment options for patients.
With dozens of biosimilars in the pipeline, the first interchangeable designation signals an important milestone for safe and effective treatments for patients with complex conditions.