On a recent episode of the AmerisourceBergen Insights podcast, our biosimilars experts offered guidance on what interchangeability really means and how pharmacies can prepare as insulin biosimilars come to market. Here are highlights from the discussion:
Q: What could the approval of Semglee® mean for the biosimilar market?
Sean McGowan, Sr. Director, Biosimilars at AmerisourceBergen: First, even though Semglee currently exists, it exists in its follow-on biologic form. This is a product that was approved and launched back in August of 2020. The Semglee that was approved in its biosimilar form was approved at the end of July 2021 but has yet to come to market. It is not commercially available yet. But as Mylan/Viatris gets closer to launch, we'll see a lot more information on the biosimilar product.
As we think about the insurance side of things, both for the pharmacy as well as the patient-payer-pharmacy benefit manager dynamic, at this point, it's one of the greatest unknowns. How will these insurance entities handle the interchangeable biosimilars? Are they going to be treated like innovator products? What will the cost for patients be? The pricing? There seems to be some optimism around the presence of an interchangeable insulin biosimilar and truly bringing down the cost for patients, which I hope is the case since this impacts tens of millions of patients in the U.S.
We're going to continue to follow this closely, understand how the dynamic of an interchangeable insulin biosimilar will work in the marketplace, how this impacts the pharmacies and the pharmacists, and most importantly, the patients. We'll lend a level of support to help everyone take advantage of the expansion of the access and choice.
Q: What do pharmacies and even patients need to know about interchangeability right now?
Michelle Jesse, Director, Biosimilar Commercialization at AmerisourceBergen: To have the best understanding of interchangeability in the U.S., it's important to refer to FDA definitions and resources. They're the gatekeepers of interchangeability approval in the U.S., so that is the best resource to continue to utilize. But first and foremost, the biosimilar manufacturer must conduct and then submit an interchangeability study to the FDA. The submission utilizes the 351(k)(4) pathway and means that the biosimilar product may be substituted for the reference product without the intervention of the prescribing healthcare provider.
Patients and prescribers can expect the interchangeable biosimilar to have the same clinical result as the reference product, in any given patient. For products administered to patients more than once, the biosimilar manufacturer must also prove there is no additional risk or reduced efficacy. If patients switch back and forth between the interchangeable biosimilar and the reference product, the point is the FDA is dedicated to ensuring patient safety for any biosimilar approved for interchangeability. And Congress is going to make sure that patients are benefiting from these biosimilar insulins. So between Congress and the FDA, the patients should be excited about that additional savings and hopefully additional access that they'll receive within the insulin market for biosimilars and interchangeability.
Q: What are the two or three actions that pharmacies can take now to prepare for prescriptions where products are interchangeable?
Michelle Jesse: My first suggestion is understanding the pipeline, landscape, and timing for the insulin biosimilar market. Pharmacies have an excellent understanding of the current insulin market and those innovator players. However, taking the time to understand the manufacturers looking to launch, the approximate launch timelines, as well as device or administration comparisons, is in my opinion, the first key for pharmacies to be successful.
Next, I would tell the pharmacies to then focus on interchangeability specifically around education and awareness. That is going to be key for these pharmacies to understand the biosimilar market and, more importantly, interchangeability and how that will affect the first insulin biosimilars that are coming soon.
Understanding how the FDA assigns and defines interchangeability is another key for success. Currently, the FDA is mandating that if a biosimilar receives interchangeability approval, that biosimilar product will only be interchangeable with the originator, innovator, or reference product, and not other competing biosimilars. Additionally, many states have different substitution laws already in place. Being able to navigate the differences in each state's law would be, in my opinion, the final key action that I would advise to the U. S. retail pharmacies. Luckily, databases and platforms are either already developed or are being developed for all healthcare providers, including pharmacies, to access details in what will possibly be a very complicated space at first to understand.
To hear the full conversation, listen to our podcast episode. To learn more about Biosimilars, download our Biosimilars Pipeline Report. Both can be found at Amerisourcebergen.com/insights.
The editorial staff had no role in this post's creation.