Congress creates abbreviated licensure pathway for biological products similar to or interchangeable with FDA-approved products.
A biosimilar product is a biologic product that is approved based on demonstrating that it is highly similar to an FDA‐approved biologic product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
Congress, through the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. This pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition.
FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference product.
Prescription medications, especially those for chronic diseases like diabetes and cardiovascular disease have become a major economic burden. Due to rising diagnosis of type 1 and type 2 diabetes, it is understandable why more cost efficient biosimilar products are being developed. Diabetes biosimilar biologic products such as GLP-1 receptor agonists, human insulins, and insulin analogues are projected to grow in the near future and will result in cost reduction of diabetes treatment. Biosmilars will also provide patients with a greater variety of insulins and insulin mimetics to choose from.
What is meant by a biosimilar product? A biosimilar is a biological product defined as being highly comparable to an already FDA-approved biological product, referred to as a reference product. Both the reference and biosimilar products are evaluated through use of various comparative tests. The two drugs are required to have similar structures, function, safety, and efficacy. However, small differences in inactive ingredients such as stabilizers and buffers are acceptable. Biosimilars have a similar molecular structure to that of the reference product but they are not identical. This is unlike generic drugs that have identical molecular structures and active ingredients to those of the brand name products.
An advantage in the development of biosimilars is they must be proven to be comparable to the reference product and therefore less clinical trials are required, cutting down the expense of the drugs and accelerating the approval process. The first biosimilar insulin, Basaglar, was introduced in the U.S in 2016. A year prior to this, it was introduced in Europe under the name Abasaglar. Basaglar was manufactured by Eli Lilly and Boerhringer Ingelheim. It was proven to be similar in function, safety, and efficacy to the brand name insulin, Lantus (insulin glargine), a long-acting insulin manufactured by Sanofi. Basaglar is technically not considered a biosimilar by the FDA in the U.S. because glargine products are not licensed under the Public Health Service Act, although it still meets the criteria of a biosimilar product and it is considered as such in Europe.
Other insulin glargine analogs are already available in Europe and some are currently under review with the FDA in the U.S. Merck developed a biosimilar insulin glargine, which was approved in Europe. Mylan and Biocon are also working together to produce a biosimilar insulin glargine (Basalog) that has already been studied in phase 3 trials. Products for brand name insulins such as Novolog (insulin aspart) and Humalog (insulin lispro) are under development and will be available in the near future, as their patents are due to expire soon. Currently Sanofi is in the process of producing a biosimilar insulin lispro and the product has been evaluated in phase 1 and phase 3 trials. Mylan and Biocon are also collaboratively working on insulin lispro and insulin aspart biosimilars. In Europe, marketing authorization applications have been turned in for many of these products and are in the process of being reviewed.
Are biosimilars the same as generic drugs? Biosimilars and generic drugs are versions of brand name drugs and may offer more affordable treatment options to patients. Biosimilars and generics are each approved through different abbreviated pathways that avoid duplicating costly clinical trials. But biosimilars are not generics, and there are significant differences between biosimilars and generic drugs. For example, the active ingredients of generic drugs are the same as those of brand name drugs. In addition, the manufacturer of a generic drug must demonstrate that the generic is bioequivalent to the brand name drug.
By contrast, biosimilar manufacturers must demonstrate that the biosimilar is highly similar to the reference product, except for minor differences in clinically inactive components. Biosimilar manufacturers must also demonstrate that there are no clinically meaningful differences between the biosimilar and the reference product in terms of safety and effectiveness.
It is not known for sure when these products will be approved in the U.S., but they are expected within the next few years. The biosimilar drug market will continue to progress as more studies are conducted and more drug patents expire. Biosimilars for diabetic medications are highly anticipated as they will provide patients with lower priced treatment therapies, more treatment options, and faster access to medications. However, in comparison to generics, biosimilar medications are still a lot more expensive to manufacture and therefore will still be less affordable, although biosimilar products still have an advantage over the brand name products when comparing costs. Biosimilars will potentially help further reduce the economic burden on patients and the healthcare system, and will help expand the options for more individualized treatment regimens.
- A biosimilar product is a biologic product that is approved based on demonstrating that it is highly similar to an FDA‐approved biologic product.
- No clinically meaningful differences in terms of safety and effectiveness can exist from the reference product.
- Biosimilar manufacturers must demonstrate that the biosimilar is highly similar to the reference product.
“Biosimilar and Interchangeable Products.” U.S. Food and Drug Administration. 23 Oct. 2017. Web. 14 Nov. 2017.
Davies M, Dahl D, Heise T, et al. Introduction of Biosimilar Insulins in Europe. Diabetic Medicine. 2017. 0: 1-14.
Mattina, Christina. Diabetes Drugs Could Be Next Frontier of Biosimilar Development. The Center For Biosimilars. 28 Feb. 2017. Web. 14 Nov. 2017.
Wright E, Blevins T, Reed B, et al. Demystifying the Differences: Follow-on Biologics, Biosimilars, and Generics. The Journal of Family Practice. 2017. 0: 1-7.
Graciela Nieto, Pharm. D. Candidate 2018, LECOM School of Pharmacy