But 3 main challenges stand in the way of their adoption: patent litigation, patient and physician concerns, and rebates and reimbursements.
The federal government, institutions, medical associations, and pharmaceutical companies must work together to address patient and physician concerns about the use of biosimilars in the United States, according to the results of a study published in Seminars in Arthritis and Rheumatism.
Biosimilars are more cost-effective versions of other biologics, but they are not a generic alternative to these products.
They are more complex, meaning that they are harder to create on a large scale and more costly, study results show.
When compared with the European Union (EU), the use of biosimilars has been relatively slow in the United States. As of September 2021, the EU had approved 80 biosimilars, while the United States had approved 31.
Therefore, investigators aimed to examine the challenges and solutions to successfully implement greater use of biosimilars in the United States.
There are 3 main challenges that the United States faces in the uptake of biosimilars: reimbursement and rebates, patent litigation, and physician and patient concerns, study results show.
Drug reimbursement is tied to the average sales price (ASP). When this is higher, the reimbursement is also higher for the insurance provider. Biosimilars with lower ASPs would deliver a lower reimbursement than the reference product.
Pharmacy benefit managers can enter into agreements where they receive rebates for reference products, which causes them to reduce financial incentives for biosimilars.
To combat this, there are insurance programs that have changed reimbursement policies to incentivize biosimilars.
Additionally, patent litigations play a large role in whether biosimilars for reference products can exist.
Often, biosimilars approved by the FDA face legal disputes by the reference product manufacturers to increase exclusivity of the drug by delaying a biosimilar from getting to market.
Many manufacturers file as many patents as possible for the reference drug. For example, Humira, from AbbVie, has 136 different patents.
For chemically manufactured drugs, the Hatch-Waxman Act created a clear patent litigation framework for generic manufacturers, so that they can challenge patents owned by brand manufacturers. Because of this act, there has been a lot of growth for generic drugs.
In 2010, a similar act was enacted for patent dispute resolutions that biosimilars face.
Another common concern for biosimilars comes from patients and physicians. They have expressed concern with changing from the reference product to the biosimilar, or in some cases, switching back and forth between them, especially if the switch is because of the price.
Patient concern is tied to concerns over efficacy, safety, and a fear that the switch will occur without their consent, while many physicians are concerned about the possibility of increased immunogenicity and increased consultation time prior to switching, as well as the need to evaluate efficacy and safety data for different indications.
Immunogenicity, which is the ability of cells and tissues to provoke an immune response to a foreign substance in the body, like a biosimilar, is presently only hypothetical, the study results show.
As a result, there are a few different paths that can be taken to increase the number and usage of biosimilars.
The federal government could increase the number of biosimilars by approving more biologics. In other systems, price competitions can increase the use of biosimilars, which can also make both biosimilars and reference drugs more affordable for patients who need them.
To help promote the prescription of biosimilars, health care systems should offer more financial incentive programs, the study results show.
Additionally, medical associations can help promote biosimilars via recommendations and guidelines.
Investigators determined that by combining these tactics, biosimilar use can increase to alleviate access to medications and the financial burden.
Kvien TK, Patel K, Strand V. The cost savings of biosimilars can help increase patient access and lift the financial burden of health care systems. Semin Arthritis Rheum. 2022;52:151939. doi:10.1016/j.semarthrit.2021.11.009