How Retail Pharmacists Can Prepare for the Semglee Biosimilar
Insulin glargine-yfgn (Semglee; Viatris) presents the first opportunity for retail pharmacists to dispense a biosimilar to patients.
Biosimilars have generated buzz since the approval of the first biosimilar in the United States back in 2015. These similar, though not identical, drugs have proven to be as safe and effective as their reference products, allowing the cost effectiveness of biosimilars as a treatment option for patients to increase their ongoing market viability.
The biosimilars that have launched in market to date are physician-administered drugs that are paid for or reimbursed under the patient’s medical benefit (Part B) plan. Patients have benefitted greatly from the expanded access, choice, and cost savings these biosimilars have ushered in, and there’s been significant growth and adoption of these biosimilars in the few markets where they currently compete.
However, biosimilars have not generally been in the purview of retail pharmacists. That’s about to change in the months ahead.
In July, insulin glargine-yfgn (Semglee; Viatris) received approval as an interchangeable biosimilar referencing the biologic drug insulin glargine injection (Lantus; sanofi-aventis US). Similar to insulin glargine injection, the insulin glargine-yfgn biosimilar is an insulin glargine product that is long-acting and indicated to treat adult and pediatric patients with type 1 diabetes and adult patients with type 2 diabetes.1
In November, insulin glargine-yfgn became commercially available to retail pharmacies (including by mail orders), making it the first biosimilar to break into the pharmacy benefit, or Part D, space.
Insulin glargine-yfgn presents the first opportunity for retail pharmacists to dispense a biosimilar to their patients. As the biosimilar rolls out across the country, there are a few items to note that will help pharmacy professionals with insulin glargine-yfgn’s entrance into retail pharmacy.
Patient Education at the Retail Pharmacy Counter
Retail pharmacists across the United States have a vital role in educating patients about the insulin glargine-yfgn biosimilar, and biosimilars overall. Some areas where patients will likely have questions include safety, efficacy, and cost.
For questions regarding safety and efficacy, the FDA has a great resource as to what is required for biosimilars to receive interchangeable status. Essentially, manufacturers generally perform switching studies to prove that patients who use the originator or biosimilar product and then switch do not experience higher rates of adverse effects or lower efficacy.2
As for questions about cost, biosimilars generally have the potential to drive down health care costs; however, with the US health care system being as vast as it is, many factors come into play, which ultimately impacts a patient’s cost at the pharmacy counter. So, making note of your patients who are prescribed an insulin glargine product and offering to work with them to help realize potential cost savings will be paramount.
State Biosimilar Interchangeability Laws
The interchangeable designation of insulin glargine-yfgn is both a distinct and important description. This means that retail pharmacists can switch out insulin glargine injection for the insulin glargine-yfgn biosimilar without the required approval from the physician who prescribed the reference product.2
For this reason, it’s important for pharmacists to brush up on their respective state’s biosimilar interchangeability laws since it varies state to state¾all 50 states plus the District of Columbia have now enacted laws in this area.
For example, some states allow for the substitution of a drug so long as a prescriber didn’t indicate an intent to prevent substitution. There are also laws that are effective until or set to be repealed by a certain date. Lastly, it may be required that a pharmacist communicates the substitution back to the patient and the prescriber, whereas other states just specify that a pharmacist needs to communicate the substitute to the prescriber.
Due to all of these variations, familiarity with respective state guidelines need to be checked on a semi-regular basis as interchangeability statutes can change.
Availability of Insulin Glargine-yfgn in Branded and Unbranded Versions
One last important piece to touch on is that there are 2 versions of insulin glargine-yfgn available¾thus, 2 different National Drug Codes. There’s an unbranded authorized interchangeable insulin glargine-yfgn, which will be sold under the molecule name, and a branded authorized interchangeable insulin glargine-yfgn, which will have Semglee on the label.
The main takeaway with these 2 versions of this biosimilar for retail pharmacists is that the branded version will be for commercial patient plans, whereas the unbranded version will be for Medicare Part D plans.
Overall, the approval and launch of insulin glargine-yfgn as an interchangeable biosimilar is promising for expanding choice, cost, and access. For retail pharmacists, insulin glargine-yfgn creates the opportunity to continue to engage with patients and identify treatments that may be more affordable.
- US Food and Drug Administration. FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes. FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes. Published July 28, 2021. Accessed December 23, 2021.
- US Food and Drug Administration. Biosimilar and Interchangeable Biologics: More Treatment Choices. FDA website. https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices. Published October 12, 2021. Accessed December 23, 2021.
About the Author
Michelle Jesse is the director of biosimilar commercialization at AmerisourceBergen.