An Inflection Point for Arthritis Treatment
As the availability of lower-cost biosimilars grows in the U.S., more autoimmune arthritis patients may be able to access them.
By Vandana Suresh | September 14, 2023
Biosimilars hold enormous promise to deliver cost-effective treatments indistinguishable from their reference biologics. With AbbVie’s blockbuster drug adalimumab (Humira) losing its market exclusivity earlier this year, its biosimilars will have the opportunity to alter the treatment landscape for autoimmune arthritis after spending years in development, approvals and regulations.
The path to commercialization for a biosimilar is different from its reference product. Due to their close structural similarity to a reference biologic, biosimilars are allowed a contracted pathway for approval. Among other requirements, the Food and Drug Administration (FDA) necessitates studies showing “no clinically meaningful difference” in safety, purity and potency between the biosimilar and its reference biologic. In some cases, clinical switching studies are needed to show the interchangeability of the biosimilar with its reference product. This additional regulatory designation allows pharmacists to substitute the biosimilar for its reference product without additional approvals from the prescribing physician.
But despite an abbreviated approval process, biosimilars have been slow to make headway into U.S. health care markets, in part due to proprietary patents on reference biologics. Biotech companies spend billions of dollars on drug development and are accorded exclusive market share for a few years by the FDA. These companies often extend their exclusivity by filing multiple patents on their manufacturing processes, which can further delay biosimilars from entering markets.
Other barriers also stand in the way of biosimilars reaching consumers. Health care systems may continue to adhere to reference biologics to reap rebate benefits. Biosimilars must also fiercely compete with their reference biologics for patient preference and physician willingness to prescribe them over reference biologics. Consequently, unresolved provider or patient concerns about immunogenicity or interchangeability could be a significant setback.
There is, however, encouraging real-world evidence from Europe and other countries on biosimilars’ long-term safety and efficacy, especially for rheumatoid arthritis treatment. For example, a recent study showed that a hospital-wide switch between adalimumab to its biosimilar Amgevita did not significantly affect patient treatment satisfaction. The study also reported no indication of increased side effects. Similar evidence also exists for the biosimilars for rituximab (MabThera, marketed in the U.S. at Rituxan) and etanercept (Enbrel), not yet available in the U.S.
To allay concerns and ease the adoption of biosimilars, the Arthritis Foundation stresses that switching from a reference biologic must be a joint decision between providers and patients. Further, the Foundation believes that health care stakeholders should be responsible for educating patients about biosimilars. As a recommendation to increase transparency, we assert that formulary changes involving biosimilars must be communicated to the patients promptly, and patients should see a reprieve in their out-of-pocket costs upon switching to biosimilars.
As many as 10 adalimumab biosimilars await their launch into the U.S. market this year. Although the extent of hiccups of their assimilation into the U.S. health care system remains to be seen, the Arthritis Foundation believes that biosimilars have the potential to benefit every stakeholder in the health care system.
The Arthritis Foundation would like to thank Dr. Mark Box for his feedback on this article.
Biosimilars hold enormous promise to deliver cost-effective treatments indistinguishable from their reference biologics. With AbbVie’s blockbuster drug adalimumab (Humira) losing its market exclusivity earlier this year, its biosimilars will have the opportunity to alter the treatment landscape for autoimmune arthritis after spending years in development, approvals and regulations.
The path to commercialization for a biosimilar is different from its reference product. Due to their close structural similarity to a reference biologic, biosimilars are allowed a contracted pathway for approval. Among other requirements, the Food and Drug Administration (FDA) necessitates studies showing “no clinically meaningful difference” in safety, purity and potency between the biosimilar and its reference biologic. In some cases, clinical switching studies are needed to show the interchangeability of the biosimilar with its reference product. This additional regulatory designation allows pharmacists to substitute the biosimilar for its reference product without additional approvals from the prescribing physician.
But despite an abbreviated approval process, biosimilars have been slow to make headway into U.S. health care markets, in part due to proprietary patents on reference biologics. Biotech companies spend billions of dollars on drug development and are accorded exclusive market share for a few years by the FDA. These companies often extend their exclusivity by filing multiple patents on their manufacturing processes, which can further delay biosimilars from entering markets.
Other barriers also stand in the way of biosimilars reaching consumers. Health care systems may continue to adhere to reference biologics to reap rebate benefits. Biosimilars must also fiercely compete with their reference biologics for patient preference and physician willingness to prescribe them over reference biologics. Consequently, unresolved provider or patient concerns about immunogenicity or interchangeability could be a significant setback.
There is, however, encouraging real-world evidence from Europe and other countries on biosimilars’ long-term safety and efficacy, especially for rheumatoid arthritis treatment. For example, a recent study showed that a hospital-wide switch between adalimumab to its biosimilar Amgevita did not significantly affect patient treatment satisfaction. The study also reported no indication of increased side effects. Similar evidence also exists for the biosimilars for rituximab (MabThera, marketed in the U.S. at Rituxan) and etanercept (Enbrel), not yet available in the U.S.
To allay concerns and ease the adoption of biosimilars, the Arthritis Foundation stresses that switching from a reference biologic must be a joint decision between providers and patients. Further, the Foundation believes that health care stakeholders should be responsible for educating patients about biosimilars. As a recommendation to increase transparency, we assert that formulary changes involving biosimilars must be communicated to the patients promptly, and patients should see a reprieve in their out-of-pocket costs upon switching to biosimilars.
As many as 10 adalimumab biosimilars await their launch into the U.S. market this year. Although the extent of hiccups of their assimilation into the U.S. health care system remains to be seen, the Arthritis Foundation believes that biosimilars have the potential to benefit every stakeholder in the health care system.
The Arthritis Foundation would like to thank Dr. Mark Box for his feedback on this article.
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