Expected launches & uptake of biosimilars in US to touch $129bn, reports IQVIA

According to IQVIA's Biosimilars in the United States 2023-2027 report (https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2023-2027), the US biologics market has grown 12.5% annually over the last 5 years, and spending is expected to reach $129 billion by 2027. Currently, biosimilars that have launched account for 24% of competitive molecule volume. There are currently 40 official?FDA-approved biosimilars?as well as 5 FDA-approved follow-on biologics, with most number of brands referencing Humira (adalimumab), followed by Neulasta (pegfilgrastim) and Herceptin (trastuzumab). Despite slower initial uptake, biosimilar launches in the last three years have generally been more successful than earlier.

The report analyzes the current state of the biologics market in the United States and looks at the share of the market facing biosimilar competition. Factors impacting biosimilar uptake, including reimbursement and provider type, and the impact of biosimilars on molecule volume and price are also evaluated. Some of the key findings of the report are highlighted below:

• The US biologics market has grown 12.5% annually on average over L5Y at a rate faster than non-biologics
• Innovator brands currently facing biosimilar competition total $38bn of invoice spending, while a further $96bn is the target of future biosimilars, either in development phase or yet to be launched
• Non-340B clinics have seen higher uptake of biosimilars than 340B clinics (hospitals and clinics that treat low-income and uninsured patients), likely due to reimbursement dynamics
• The introduction of biosimilars frequently leads to higher utilization of the molecule as lower costs offer increased access to patients. However, more innovative alternative treatments can lead to volume declines as patients are moved to these successive generation products.
• Expected launches and uptake are likely to increase overall spending on biosimilars significantly to $20–$49Bn in 2027 and cumulative sales of $129Bn over the next five years, with at least 10 molecules facing biosimilar competition over the period.
• The three classes with the highest spending — immunology, antidiabetics, and oncology — account for 70% of biologics spending, and their biologics growth is at 18.4%, 12.3%, and 14.8% CAGRs, respectively, in the past five years.
• The three oncology molecules with biosimilar launches in 2019 — bevacizumab (82%), trastuzumab (80%), and rituximab (67%) — achieved significant uptake within the first three years of commercialization.
• Introduction of lower cost biosimilars leads to declines in overall molecule costs per unit (including both originator & biosimilars) over time, typically driving down costs for originators as well. Bevacizumab and trastuzumab have had the most rapid decline in cost per unit, indicating strong biosimilar uptake
• The most impactful biosimilars brands in the next five years — those referencing Humira (eight already approved) — will begin to appear in H1 2023 as a result of negotiated patent litigation settlements. As they reach the market, patients will undoubtedly benefit from lower costs to receive the world’s biggest pharma blockbuster drug.

Interestingly, IQVIA has also noted that more small drug companies are breaking into the biosimilars space. Earlier, smaller manufacturers would partner with big pharma companies to support marketing functions. In 2020, smaller companies marketed only 9% of biosimilars. In comparison, today 79% of biosimilars that are under development are being developed by smaller companies with varying degrees of biologic or biosimilar R&D capability & experience.

Overall, the report definitely highlights the resiliency of the biosimilars market and provides evidence that patient access to biosimilar medicines expands access and yields remarkable savings.

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