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Five Quick Facts to Know About Biosimilars
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The biosimilar space continues to grow, with key focuses around retina and oncology, but adoption remains slow in the United States.
Biosimilars are considered highly similar to the reference biologics, while improving affordability and accessibility for patients. The potential cost savings of biosimilars are widely discussed, with many experts feeling that the space still has potential that remains unmet. Even with the FDA regulations of biosimilars, which ensure that biosimilars have comparable safety and efficacy to the reference product, there is limited uptake from prescribers. Prescribers and patients continue to express concern about the safety and efficacy of biosimilars compared with the reference product.1
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Below are 5 key facts about biosimilars, recapping the current landscape of biosimilars as well as potential for growth.
- The biosimilar space continues to grow rapidly. By the year 2031, the global biosimilar market is projected to reach approximately $92 billion, with a compound annual growth rate of 16.4% from 2023 to 2031. For 2024, the biggest projected market growth is the retina space, which has seen considerable approvals since January. Over the 2023 to 2031 period, oncology is expected to have the fastest growth rate, including development and approvals. Other key areas that have the potential for growth include inflammatory and autoimmune disorders, chronic diseases, blood disorders, growth hormone deficiency, and infectious diseases. However, diabetic insulin biosimilars are expected to see rapid growth as well, especially because diabetes is considered one of the most prevalent global diseases.2-4
For More Coverage on Biosimilar Growth and Cost:
Biosimilar Market Expected to Grow to $92 Billion by 2031, Data Show
Biosimilars in Retina Space Expected to Grow in 2024, Coming Years
Report: Oncology, Immunology Projected to Lead Global Spending From 2024 to 2028
- Adoption in the US is slow, But rapidly growing in European Union (EU). In a session at the 2024 Advanced Topics for Oncology Pharmacy Professionals Summit, presenters discussed how the EU created a competitive market dynamic for biosimilars, with 22 successful molecules in the market. In the United States, 15 molecules were approved by the FDA, but 10 were on the market as of June 2024, with only 38 competitors in the biosimilar space. However, between 2015 and 2022, biosimilars resulted in more than $20 billion in cost savings across the US health care system, even with less availability and competition compared with the EU. Barriers to adoption can include the complexities of the US health care market, low awareness on biosimilars, and reluctance of health care practitioners and patients. Although adoption has improved, there was a lower-than-expected rate of adoption for adalimumab in 2023, highlighting how difficult the market can be for meaningful traction.5,6
For More Coverage on Biosimilar Adoption:
EU Leads in Biosimilar Market Access While US Lags Behind, Faces Challenges in Adoption
Looking Back to Go Forward: What 2023 Has Taught Us About Biosimilar Adoption
- Patient and provider hesitation persists and is a barrier to uptake. Patients can be hesitant to switch from a brand name product to a biosimilar due to concerns about quality, safety, and efficacy. In a survey published by ACR Open Rheumatology, patients recommended that transitions include conversations before the switch, clear reasons for the change and cost information, matching the patient support program to the originator product, and other resources. Furthermore, attitudes, practical implications, and psychological factors have impacted widespread uptake and adoption of biosimiliar drugs, including lack of information about the interchangeability designation, education gaps, and concerns around safety and efficacy, especially among providers.7,8
For More Coverage on Patient and Provider Hesitation:
Understand Patient Experiences With Biosimilar Transitions
Attitude, Education Among Non-Economic Barriers Hinder Adoption of Biosimilars
- Lingo and interchangeability status causes confusion. Although most physicians understand the differences between biosimilar medications and generic drugs, the terminology between biologics and biosimilars can be similar, causing confusion. Furthermore, there have been concerns around immunogenicity of biosimilars as well as establishing biosimilarity and safety since the approval process differs from other drugs. The term "interchangeability" is a designation from the FDA with regulating properties; the designation itself does not determine whether the drug is biologically similar to the reference product and can be substituted for the reference product. When a biosimilar is approved, it is because the biosimilar has established immunogenicity, biosimilarity, and safety compared with the reference product. For the designation, the regulation allows an interchangeable biosimilar to be approved at the pharmacy level, without consultation from a provider, much like generic drugs.9,10
Read More Coverage on Biologics and Interchangeability Status:
Learning the Lingo of Biologics and Biosimilars Is Critical
Interchangeability Designation Still Widely Debated, Prescribers Hesitant About Biosimilars
- Pharmacists continue to be leaders in education about biosimilars. Pharmacists play a critical role in education for both patients and prescribers when it comes to biosimilars, either as a whole or for a specific biologic. Through counseling, they can inform patients about the differences between reference products and biosimilars so that patients can make informed decisions about their health. Pharmacists should also continue to educate themselves about the changing landscape of biosimilars so that they can continue to counsel patients accurately.11
Read More Coverage on the Pharmacist’s Role:
