Cardinal Health announced that it has launched an interactive map for interchangeable biosimilars. The tool provides pharmacists with key guidance to help them navigate the recent FDA approval of the first interchangeable biologic licensed in the United States. This approval was granted to Semglee (insulin glargine-yfgn), which is now designated as a biosimilar for one of the most frequently used and costly biologic treatments on the market today—insulin.
With this approval, pharmacists now have the ability to substitute a biosimilar for its brand-name product without the intervention of the prescribing physician, which can help patients access insulin at a lower cost.
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. The interactive map is designed to help users navigate their state’s specific guidelines and support patients with biosimilar adoption. It provides information on the specific laws for each state, including the following:
- The definition of interchangeability;
- Whether a pharmacist can automatically substitute an interchangeable biosimilar for the originator biological, without previous approval;
- Whether prescribers can prevent automatic substitution, eg, by writing “dispense as written” or “brand medically necessary”;
- Whether pharmacists have to communicate the substitution back to the prescriber and/or patient, and how this should be communicated and the timeline for such communication; and
- Whether there is any legal immunity for pharmacists who make a substitution in compliance with biological state law.
“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,” stated Sonia T. Oskouei, PharmD, Vice President, Biosimilars, Cardinal Health, Atlanta, GA, in a company press release.