New tool is designed to help pharmacies navigate state-by-state interchangeability laws for the FDA’s new regulatory designation
Cardinal Health has created an interactive tool that provides pharmacists with key guidance to help them navigate the recent Food and Drug Administration (FDA) approval of the first interchangeable biologic licensed in the U.S. The FDA approval was given to the long-acting insulin called Semglee (insulin glargine-yfgn), which is now designated as a biosimilar for one of the most widely used and costly biologic treatments on the market today – insulin.
“The approval of the first interchangeable insulin biosimilar is a big step toward helping bring more affordable diabetes care to the millions of Americans who rely on insulin.”
~Sonia T. Oskouei, vice president of biosimilars at Cardinal Health.
Biosimilars are biologic products that are highly similar to and have no clinically meaningful differences from existing FDA-approved branded biologics.
The FDA’s interchangeability designation will give pharmacists (subject to state law) the ability to substitute a biosimilar for its brand-name product without the intervention of the prescribing physician, similar to a generic. This may put pharmacists in a position to help diabetes patients access their insulin at a lower cost.
Semglee will be the first biosimilar available to a broad patient population through retail pharmacies. Cardinal Health created its interactive map to help pharmacists get up to speed quickly on biosimilars and interchangeability, so they’re able to appropriately educate their patients about their treatment options. Pharmacy laws and practices vary from state to state, particularly when it comes to managing interchangeable biosimilars. State laws include specific requirements related to provider notification and permission, patient communication and documentation practices. Our map details how states define interchangeability, clarifies whether pharmacists can substitute biosimilars, and defines what healthcare providers and pharmacists need to know about switching to a biosimilar.
“The approval of the first interchangeable insulin biosimilar is a big step toward helping bring more affordable diabetes care to the millions of Americans who rely on insulin, but many patients will have questions,” said Sonia T. Oskouei, vice president of biosimilars at Cardinal Health. “As some of the most trusted and accessible healthcare providers in their communities, pharmacists will play an essential role in educating patients about biosimilars, building clinical confidence in these products, and guiding patients toward therapies that deliver the best outcome at the lowest cost. Our map is designed to give pharmacists the answers they need on state-level interchangeability requirements.”