FDA approves first interchangeable biosimilar insulin
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The FDA approved the first interchangeable biosimilar insulin product to improve glycemic control for children and adults with diabetes, part of an effort to provide cost-effective options, according to an agency press release.
Semglee (insulin glargine-yfgn, Mylan) is both biosimilar to and interchangeable with its reference product insulin glargine (Lantus, Sanofi), a long-acting insulin analogue. As Healio previously reported, Semglee was approved as a drug product under the 505(b)(2) NDA pathway and is now deemed a biologic under section 351(a), in accordance with the Biologics Price Competition and Innovation Act.
“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” Acting FDA Commissioner Janet Woodcock, MD, said in the release. “Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”
A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA. An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called pharmacy-level substitution, subject to state pharmacy laws, which vary by state. In the release, the FDA noted that biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products; however, experts have debated whether biosimilar insulin products will substantially lower cost to patients.
“Access to affordable insulin is critical, and long-acting insulin products, like insulin glargine, play an important role in the treatment of types 1 and 2 diabetes mellitus,” Peter Stein, MD, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, said in the release. “The FDA’s high standards for approval mean health care professionals and patients can be confident in the safety and effectiveness of an interchangeable biosimilar product, just as they would for the reference product.”
Semglee is available in 10 mL vials and 3 mL prefilled pens and is administered subcutaneously once daily. Dosing of Semglee, like Lantus, should be individualized based on the patient’s needs and should not be used during episodes of hypoglycemia or for patients with hypersensitivity to insulin glargine products.
The approval for biosimilar insulin glargine was based in part on the INSTRIDE studies, which confirmed the pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity of Semglee compared with Lantus for people with type 1 and type 2 diabetes. Mylan announced the U.S. launch of Semglee in August 2020, noting in a press release at the time that it was seeking an interchangeability designation from the FDA.
The launch came after favorable judgments on all remaining patent claims asserted by Sanofi against Mylan's insulin glargine products.
“Although Sanofi may seek certain appeals of those judgments, Mylan is confident they will not affect commercialization,” the company stated in their release.
In March 2020, the FDA announced the formal transition of insulin and certain other biologic drugs to a new regulatory pathway that will better facilitate the development of biosimilar or interchangeable products. In an agency statement, FDA stated that a small subset of biological products approved under the Federal Food, Drug and Cosmetic Act, such as insulin and human growth hormone, will transition to being officially regulated as biological products, enabling these drugs to serve as the reference product for biosimilar or interchangeable drugs approved through the abbreviated licensure pathway. Prior to this change, the FDA required any follow-on insulins to be approved under the abbreviated new drug pathway; these insulins were not considered to be biosimilar because insulins were approved and regulated as chemical drugs.
The FDA released new materials for health care providers to enhance understanding about biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products, according to the agency.
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When I first saw this news, my first thought was, “Can we make this the insulin for the County of Los Angeles?” Here, we still use NPH insulin in many cases, especially for people with type 2 diabetes. I am not sure that Semglee will be cheaper than the $4 a vial paid for NPH. That said, I hope with the discount coupon programs that are available, this insulin will be more affordable for people paying out of pocket.
The good thing here is price — hopefully, this drives prices down, not up. From a patient perspective, it may mean that they can easily get a less expensive insulin at the pharmacy without requiring the pharmacist to call the doctor for a substitution. However, that can also be a bad thing. There are patients, particularly with type 1 diabetes, who may feel there are differences between the brand name and the biosimilar and will not want this change, especially without a conversation with their doctor. This new biosimilar could also confuse some doctors; there will be a need for more education to stress that these two insulins are, in fact, the same.
Finally, the pen devices differ. Some may prefer the branded Lantus pen device vs. a Semglee pen device.
I have long wished there was an interchangeability among insulin analogues, so it was easier for switching. On the other hand, I have so many patients who get upset about switching, because they feel comfortable with what they are prescribed. This approval is good if it makes insulin less expensive and more accessible. I just want to make sure we do not limit patient choice.
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Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP
Insulin has been around for 100 years, yet cost is a serious issue that too often leads to insulin rationing. Recently, there has been more attention to this issue, and many organizations have compiled insulin cost-savings tools like www.getinsulin.org. In June, Walmart announced it would sell ReliOn brand insulin aspart for a lower cost.
Semglee (insulin glargine) is now the first interchangeable biosimilar insulin product. It will allow pharmacists to make the direct substitution for Lantus (insulin glargine) when it is preferred by insurance providers or a lower cost option for the patient. It is widely available at the pharmacies. This product is nearly identical to Lantus and is expected to have the same outcomes on blood glucose management.
Due to the complexities of the drug pricing system and rebates from pharmaceutical companies, a lower list price does not necessarily mean that Semglee will be preferred by insurance providers. For example, insulin aspart and insulin lispro are both available as generics, yet often insurance providers prefer the brand name Novolog (Novo Nordisk) and Humalog (Lilly), respectively. Although it is a direct substitution for Lantus and is expected to have identical effects unit per unit, patients should know that they still have the choice to continue using Lantus if they prefer. Their prescriber can also choose to not allow for the substitution when writing the prescription.
Overall, it is great to see we are moving in the right direction with insulin affordability, but there is still much work to be done to ensure no one has to ever ration insulin.
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Satish Garg, MD
This is a good thing. Interchangeable means that a pharmacist can now automatically substitute the branded insulin for the patient with the biosimilar, without making a phone call to the doctor or the insurance company. I hope, as more players enter the market, that cost for biosimilar insulins will go down. It is the same insulin. That said, about 10% of patients do not want to change what they have been using for years; however, most of the time, the cost savings will drive people to accept it.
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