Uptake of biosimilars in the United States remains suboptimal and requires intervention
Compared to the European Union, the use of biosimilars in the United States is lagging behind, and the US government, health systems and medical associations all have a role to play.
While biosimilars have the potential to improve access to treatment while saving patients and healthcare systems significant money, uptake in the United States has been suboptimal, underscoring the need to adapt strategies like those of the European Union to improve the acceptance of biosimilars, according to an article published in Seminars on arthritis and rheumatism.
As of January 1, 2022, the United States has approved 33 biosimilars, the most recent being Yusimry, a biosimilar to adalimumab, and Rezvoglar, a biosimilar to insulin glargine. Although biosimilars are often described as similar to generic versions of biologics, this is not the most accurate definition, according to the authors.
Biosimilars are much more complex, as they cannot be chemically synthesized on a commercial scale, and therefore are more expensive to develop than generic drugs, they explained. “A generic may cost only $1-4 million and take 2 years to develop versus $100-250 million and 7-8 years for a biosimilar.”
Not only are biologics expensive, but their increasing use has significantly contributed to rising health care costs. Despite accounting for just 2% of prescriptions in the United States, biologics account for nearly 40% of prescription drug spending, the authors wrote.
Biosimilar approval requirements in the United States and the European Union are broadly similar, but there are 2 major differences: the European Medicines Agency requires a post-market surveillance plan and individual European countries, not the regulatory agency, decide on the interchangeability or the passage of the product reference.
The EU’s first biosimilar was approved in 2006, and since then it has approved 80 in total, although only 74 remain authorized as of January 1, 2022. a few years there has been a significant increase in use biosimilars in the EU,” the authors wrote.
The wider use of health technology assessment has led decision-making bodies, such as the UK’s National Institute for Health and Care Excellence, to ask providers to use the cheapest treatments to start with. Belgium and Germany have systems in place that have resulted in the prescription of biosimilars to 40% of patients. Norway’s incentives to switch to biosimilars have resulted in market shares of 80% or more for some biosimilars.
“The systems in place in EU countries support increased use of biosimilars,” the authors wrote. “This contrasts with what is happening in the United States where, of the $126 billion spent on biologics in 2018, only about 2% was spent on biosimilars.”
The authors highlighted these barriers to the adoption of biosimilars in the United States:
- Reimbursement and tariffs: Because biosimilars have a lower average selling price, under the current system, a biosimilar offers a lower reimbursement. A pharmacy benefit manager with an agreement to receive discounts for use of the reference product has little financial incentive to offer the biosimilar.
- Patent litigation: AbbVie holds 136 patents on Humira. While 7 Humira biosimilars have been approved as of August 2017, AbbVie, the maker of Humira, has reached agreements with biosimilar manufacturers to delay the launch of their products until 2023.
- Physician and Patient Concerns: There have been concerns in several countries about switching from the reference product to a biosimilar, particularly for non-medical reasons (eg cost). Doctors have raised concerns about increased immunogenicity as a result of the switch, although this increased risk is “purely hypothetical”. Patient concerns relate to safety and effectiveness and the idea that their medication could be changed without their knowledge.
The authors note that the US government, medical associations and health systems all have a role to play in increasing the use of biosimilars. Updating guidelines, improving communication and education of healthcare providers, and offering financial incentives can all increase the use of biosimilars in the United States.
Additionally, more biosimilars approved for interchangeability may improve uptake, as pharmacists will be permitted or required to dispense interchangeable biosimilars in certain situations based on laws passed in all 50 states and the District of Columbia.
“The relaxation of interchangeability standards, clarification of regulatory requirements and post-approval changes, and increased funding opportunities for switch studies may encourage more biosimilar manufacturers to seek interchangeable designation in the United States. United,” the authors wrote.
Kvien TK, Patel K, Strand V. Biosimilar cost savings can help increase patient access and ease the financial burden on healthcare systems. Semin Arthritis Rheum. Published online December 30, 2021. doi:10.1016/j.semarthrit.2021.11.009