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04/18/2022

Sufficiently similar: What the FDA approval of the first interchangeable biosimilar product means for pharmacists

The approval means that pharmacists will be allowed to switch out Lantus (insulin glargine) for the Semglee (insulin glargine-yfgn) biosimilar without the required approval from the prescribing physician.

For the first time ever, a biosimilar is available at the pharmacy counter.

Biosimilars are biologic products that, while not exact copies, are highly similar to a reference biologic product. They are approved by the FDA to have no clinically meaningful differences in safety and efficacy compared to their reference products, yet they are often more cost-effective.  

Since the approval of the United States’ first biosimilar in 2015, biosimilars have been viewed as a promising new class of therapeutics and as a favorable option for curtailing rising drug costs. In fact, projections are citing as much as $100 billion in savings from 2020 through 2024, with effective biosimilar adoption. To date, the biosimilars currently available on the market are physician-administered drugs that are paid for or reimbursed under the patient’s medical benefit Part B plan. Patients have benefited greatly from the expanded access, choice and cost savings that these available biosimilars provide, and we have seen significant growth and adoption of these biosimilars in the markets where they currently compete.

But there is a change on the horizon that will exponentially expand the biosimilar market and that has the potential to positively impact millions more patients. With updated FDA regulations, Viatris’ (formerly Mylan) Semglee (insulin glargine-yfgn) received approval as an interchangeable biosimilar referencing Sanofi’s basal insulin, Lantus (insulin glargine). Both insulin glargine products are long-acting and indicated to treat adult/pediatric patients with Type 1 diabetes and Type 2 diabetes for adult patients only. 

[Read More: Test to treat: Pharmacists nationwide need to have prescriptive authority for COVID-19 antivirals]

And with Semglee (insulin glargine-yfgn) commercially available to retail pharmacies (including mail orders), it is the first biosimilar to break into the pharmacy benefit, or Part D, space. This gives pharmacists in the United States their first opportunity to dispense a biosimilar to their patients.

So what does this development mean for pharmacists across the country?

The interchangeable designation of Semglee (insulin glargine-yfgn) is a unique and important designation. It means that pharmacists will be allowed to switch out Lantus (insulin glargine) for the Semglee (insulin glargine-yfgn) biosimilar without the required approval from the prescribing physician. 

Additionally, we can view Semglee’s (insulin glargine-yfgn) entrance into the pharmacy space as a precursor for future biosimilar products that will fall into this pharmacy benefit space. Semglee (insulin glargine-yfgn) presents pharmacists with the opportunity to understand how best to educate and inform patients about interchangeable biosimilars and what they mean from a clinical and cost perspective. With the successful adoption and utilization of Semglee (insulin glargine-yfgn) at the pharmacy counter, pharmacists will be well-positioned to put this experience to use for anticipated biosimilar launches in the coming years, too, including at least seven biosimilars referencing Humira that will be available in 2023.

[Read More: Addressing nonadherence: What pharmacists can do]

All in all, the entrance of biosimilars in the United States’ retail pharmacy space is expected to continue, and pharmacists’ roles in dispensing to and educating patients at the counter will be paramount. The trusted relationship between patients and their pharmacists is invaluable. The introduction of biosimilar products creates a great opportunity for pharmacists to continue engaging their patients about their health conditions to help identify more affordable alternative treatments, all while still ensuring they have continued access to the therapies they need.

Elizabeth McMahon, senior vice president, emerging therapies and channel strategy, AmerisourceBergen.

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