Search for articles or Rx savings
For many patients with diabetes, particularly those with Type 1 diabetes, insulin is a key part of managing glucose levels and preventing complications. However, many patients may have trouble getting the insulin they need, whether due to high costs or limited options. While many brand-name medications are widely available as cheaper generic alternatives, such options are often less accessible for insulin products.
With insulin now being categorized as a biologic product, the development of insulin biosimilars has gained momentum. These biosimilar products are highly similar to their reference insulin products and have no clinically meaningful differences in terms of safety and efficacy. However, many patients may not be familiar with biologic products, biosimilars, and interchangeable biologic drugs.
6 common patient questions about insulin biosimilars
Read on to explore insulin biosimilar medications and how to answer common patient questions about them.
1. Is insulin a biologic medication?
Yes, as of March 2020, insulin is considered a biologic product by the FDA. Biologic medications are derived from living organisms and include a wide range of prescriptions used to treat different medical conditions, such as cancer and diabetes. Unlike chemically synthesized drugs, biologic products are more complex in how they’re manufactured.
The change from insulin as a drug to a biologic has paved the way for the development of biosimilar products. As a result, the market for insulin should see increased competition and potentially lower costs for insulin products.
2. What are insulin biosimilars?
Insulin biosimilars are medications that are highly similar in structure to insulin biologics and are as effective as the original products, also known as reference products. Insulin biosimilars work similarly to generic drugs, offering a more cost-effective alternative without compromising on efficacy or safety. In addition, the names of biosimilars are typically designated with four letters after the reference product names to differentiate the biosimilars.
3. Are insulin biosimilars available?
Currently, available insulin biosimilars on the market include:
- Semglee (insulin glargine-yfgn): A long-acting insulin glargine biosimilar, comparable to brand-name Lantus. It was first approved in June 2020.
- Rezvoglar (insulin glargine-aglr): A long-acting insulin glargine biosimilar, also comparable to brand-name Lantus. It was first approved in December 2021.
Because proprietary manufacturing processes of biological medications are not available, it can be difficult for companies to develop biosimilar drugs. For that reason, there are currently only two insulin products available on the market.
Still, you may want to stay informed about the availability and application of insulin biosimilars, as they can be a valuable part of a diabetes treatment plan. Ongoing research on biosimilar insulin will likely bring more products to market, expanding the available choices for patients while bringing down the costs.
4. How do biosimilars differ from interchangeable biosimilar products?
Biosimilars and interchangeable biosimilar products are both types of medications designed to act similarly to their reference biologic products. However, there are key differences in their regulatory status and potential uses. The main differences lie in their ability to be substituted for the reference product without a consultation with a healthcare provider.
A biosimilar is a biological product that is highly similar to its reference product, with no meaningful differences in effectiveness or safety. Regulatory bodies such as the FDA conduct thorough tests to confirm that they meet safety, purity, and potency standards. However, biosimilars are not considered identical or interchangeable with their reference products without a healthcare provider’s approval.
In contrast, an interchangeable biosimilar is a special designation given to a biosimilar that meets additional requirements beyond biosimilarity. The term “interchangeable” means the medication can be safely substituted for its reference product at the pharmacy without the need for additional approvals from the prescribing healthcare provider, state law permitting. Researchers conduct additional tests to ensure the interchangeable biosimilar and the reference product produce the same clinical outcomes.
The two currently available biosimilar insulins, Semglee and Rezvoglar, are both interchangeable with Lantus. The FDA Purple Book database can be a good resource to determine whether a biologic drug is interchangeable.
5. Are insulin biosimilars cheaper?
High insulin prices have been a growing concern for the millions of patients taking insulin in the U.S., with some patients paying as much as $400 per month out-of-pocket. This has led to 1 in 4 insulin users limiting their intake to save money, which increases the risk of diabetes complications. However, with the introduction of biosimilar insulins, there may be a solution for the high costs of insulin.
Insulin biosimilars have the potential to greatly lower the cost of treatment for diabetes patients. Factors that influence the potential cost savings from biosimilar insulins include:
- Regulatory pathways: Although insulin products are considered biosimilars, they are still currently approved by the FDA through the existing 505 (b) (2) NDA pathway. This process may be less expensive and faster than that required for typical biologics.
- Interchangeability: Interchangeable biosimilars are not classified the same way as brand and generic drugs. However, as more products get approved, they may serve a similar function in lowering the costs of biologic therapy. In addition, market competition may lead to reduced prices, making diabetes treatment more accessible.
Currently, there are no other insulin biosimilar products except for the two approved ones that are interchangeable with Lantus. However, short-term, rapid, prandial, and bolus insulins may be available in biosimilar forms in the future.
6. Will my insulin be substituted without my knowledge?
Pharmacy laws and practices regarding biosimilar interchangeability can vary by state. As interchangeable insulin biosimilars continue to gain attention in the pharmaceutical industry, it can be a good idea to stay up-to-date on state laws and new developments. That way, you can help support patients and healthcare providers who may have questions about new insulin products.
Some key elements pharmacists should be aware of when it comes to pharmacy laws and interchangeable biosimilars may include:
- Provider notification/permission: Communicating with prescribing healthcare providers may often be necessary when substituting a biologic medication for a biosimilar.
- Patient communication: Informing patients about the substitution and discussing its safety and efficacy can help them understand and be comfortable with the change.
- Documentation practices: Maintaining records of substituted biological products, as mandated by state law, can help protect patient safety and uphold potential legal requirements.
The American Pharmacists Association provides valuable information on the regulations affecting the dispensing of biosimilars.
Bottom line: Counseling on affordable alternatives
Insulin biosimilars have become a potentially valuable option for patients with diabetes, offering cost savings while maintaining efficacy. With the FDA’s recent efforts to streamline the approval of biosimilars, pharmacists are in the right position to educate and counsel patients on these products.
For example, when counseling patients, you can explain that insulin biosimilars are more affordable alternatives that have undergone FDA evaluation for safety and efficacy. However, while biosimilars don’t require companies to repeat lengthy clinical trials that were conducted for the original product, additional studies are needed to confirm their uses.
Encourage patients to consult a healthcare provider about any concerns with switching to a biosimilar insulin. With the right knowledge and training for insulin biosimilars, you can help your patients manage their insulin needs.