Semglee, a long-acting insulin analog, has been approved by the FDA as an interchangeable biosimilar with Sanofi’s Lantus. The Biologics Price Competition and Innovation Act (BPCI Act) was enacted in the U.S. in 2009, allowing the FDA to approve biosimilar drugs, or biological products with no clinically significant differences from their reference products. To the surprise of many healthcare stakeholders, fewer biosimilar approval applications have been filed with the FDA over the past decade than expected. Some reasons include potential litigation and a low return on investment; plus some that have been filed did not meet the FDA’s criteria to qualify as a biosimilar.
The Biosimilar Insulin Access Act of 2020 helped focus on the need for insulin therapy biosimilars to be interchangeable with their reference products by streamlining the approval process. Hopefully, this special designation will allow more interchangeable biosimilar insulin products to be approved in the near future.
Why is an interchangeable biosimilar insulin important?
Biologic and biosimilar agents follow different regulatory processes than brand and generic drug products. For the FDA to approve a biologic agent as “biosimilar” to a reference biologic, specific criteria need to be met. This biosimilar agent will also need to be approved as an “interchangeable biosimilar” for a pharmacist to be able to substitute it for the reference biologic without prescriber intervention.
Interchangeable biosimilar products are not classified the same way as brand and generic drugs, but as more of these products are approved, it may serve a similar function of bringing down costs of biologic therapy.
In the case of insulin therapy, classified as biologic products, a patient is likely being prescribed these agents because their blood sugar levels are elevated. If a patient doesn’t get their insulin filled because of cost or barriers related to access, they will likely experience complications from prolonged high blood sugar levels.
A 2016 article on medication adherence in patients with type 2 diabetes reviewed retrospective and observational studies and found up to 93% incidence of poor adherence. One reviewed study revealed that 31.4% of new prescriptions for diabetes-related medications were never filled and that nonadherence was “particularly relevant among patients who are refusing to initiate insulin.”
If a patient brings a prescription for a brand name non-biologic drug into a pharmacy, and there is an approved generic version available, the pharmacist could substitute it and save the patient a significant amount of money. Pharmacists can’t do that with a biosimilar agent unless it is also classified as interchangeable. That pharmacist would have to call the prescriber for authorization to substitute the biosimilar agent. Unless the prescriber can be contacted immediately, the patient would have to wait for approval, maybe for hours or even days. The delay in therapy means the patient’s condition is likely uncontrolled or worsening. The patient may get frustrated by the drug costs or the time-consuming process of getting approval and not come back to obtain their medication. An interchangeable option allows for an immediate solution while the patient is still in the pharmacy, potentially avoiding delays in therapy and improving adherence.
Barriers to insulin therapy acceptance
There is a lot of stigma associated with insulin:
- Patients fear injections.
- Patients hear horrible rumors about the effects of insulin from family members and friends — for example, that they will need amputations. In actuality, amputations often occur after prolonged periods of poor glucose control from not taking insulin, not because a patient took insulin.
- Patients may believe “there’s something wrong with me” if they get to the point where they need insulin. This is exacerbated by clinicians who use insulin as a threat of what will happen if patients don’t adhere to wellness regimens and other first-line therapies.
Today, it’s easier to administer and obtain insulin. It’s possible the accessibility of biosimilars could help overcome the cost issue, as they may cost up to half as much as brand-name products. The trust issue may be harder to overcome.
What clinicians need to know about biosimilar insulin products
Prescribing or dispensing biosimilar insulin products shouldn’t be much different than incorporating the reference product into your practice.
A prescriber who’s experienced with diabetes care may be more comfortable prescribing biosimilars depending on their personal experiences with patients using these medications. Other prescribers who have less experience with diabetes may not even know there are biosimilar options for insulin therapy.
Pharmacists are in a position to be primary educators for prescribers and patients and to become champions for the use of interchangeable biosimilar insulin products to help reduce the cost of insulin therapy.
Be aware: There’s always the possibility that something could change with a patient’s blood sugars when switching insulin therapies; this is equally true when switching between different insulin glargine products. Pharmacists and prescribers should instruct patients to closely monitor blood sugar levels for at least a few weeks after any change in insulin therapy, and to contact their diabetes care provider if there are concerns about their blood sugar levels.
There are many more biologic products on the market than there were even five years ago. It is important for providers to be advocates for using biosimilar products when they present appropriate therapeutic alternatives.
To stay current with the constant changes to approvals and evidence regarding biosimilars, clinicians should refer to:
- The FDA Purple Book
- Lexicomp drug monographs – Lexicomp also contains a link to the Purple Book
- Published literature on biologics in practice – there are several references out there, but this one from the American Journal of Health System Pharmacists is recommended as a primer for pharmacists who are familiarizing themselves with biosimilars
Learn more about the latest insights and best practices in the eBook “Diabetes care: Equipping patients to make lasting lifestyle changes.”
