FDA Approval of Interchangeable Biosimilar Means Patients Will Have Greater Access to Affordable Medications Provided by Local Pharmacists, Pharmacies

In an historic move last week, the Food and Drug Administration (FDA) approved Semglee (insulin glargine-yfgn) as the first interchangeable biosimilar product. With this approval, pharmacists will be able to substitute the newly approved Semglee (insulin glargine-yfgn) for Lantus — another long-acting insulin — at the pharmacy level without the intervention of the prescriber and in accordance with state biosimilar substitution laws. The emergence of interchangeable biosimilars follows over a decade of advocacy by NACDS in support of policies to enhance pharmacies’ ability to provide these medications to patients.

More than 34 million Americans are diagnosed with diabetes, and access to affordable insulin is critical in the treatment of Type 1 and Type 2 diabetes. The new FDA approval of Semglee (insulin glargine-yfgn) opens the door to market competition for insulin products, improving the availability of more affordable medications that highly trained pharmacists can substitute at the pharmacy level to the benefit of their patients.

At the federal level. In 2010, Congress acted to promote the availability of biosimilars (essentially generic versions of biological medications that contain no clinically meaningful differences in terms of safety, purity and potency of the product compared to the original branded version) by enacting the Biologics Price Competition and Innovation (BPCI) Act, which NACDS strongly supported.

Of critical importance, the BPCI Act established the regulatory approval pathway necessary for the FDA to be able to approve biosimilars and designate biosimilar medications as “interchangeable”— meaning that a biosimilar product may be substituted by pharmacists “without the intervention of the [prescriber].” This move has helped to lay the groundwork for patient access to more affordable versions of biological medications that previously had faced no other market competition.

Since its enactment in 2010, the FDA has been working to implement the drug approval pathway for biosimilars and has provided guidance for demonstrating interchangeability in accordance with the requirements outlined in the BPCI Act.

At the state level. Concurrent with advocacy at the federal level, NACDS and its member pharmacies worked alongside allied stakeholders and organizations in recent years to ensure that state laws provided that pharmacists are permitted to substitute more interchangeable biosimilars as those products are approved by the FDA and become available for dispensing to Americans who need them.

Pharmacies remain committed to helping patients obtain cost-effective healthcare. As more interchangeable biosimilars come to market, pharmacists will be ready to intervene on patients’ behalf to identify and dispense more affordable medications as allowed under their state laws of practice.

Historically, the high prices of specialty biological products have placed medications out of reach for many patients. The availability of interchangeable biosimilars — such as the newly approved Semglee (insulin glargine-yfgn) — opens the door for significant healthcare savings, and most critically, improves access to affordable medications for patients requiring medications to manage their healthcare conditions.