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A positive road ahead for biosimilars?
Jan 13, 2021
From a slow and steady start to a sudden acceleration, the trajectory of biosimilars has changed – and according to current projections, will continue on an upward path. Previous slow uptake and lower than expected savings have raised questions about how successful biosimilars would be for stakeholders. Our analyses suggest we have reached an inflection point, with recent and predicted events indicating biosimilars may offer substantial savings.
With continued increases in biologics spending expected, the biosimilars market presents an opportunity for these system savings. In 2019, biologics comprised 43% of total U.S. medicine invoice spending, equating to $211 billion. Biologics spending has substantially increased since 2014, at a compound annual growth rate (CAGR) of 14.6%, which is considerably higher than the 1.6% CAGR for small molecules. Biosimilars and their originator products comprised $40 billion in spending in 2019; importantly, this spending was across several key therapy areas where further biosimilar entry could have the greatest impact. Looking forward, the immunology market — including the autoimmune market with blockbusters like adalimumab (Humira) — is almost only biologic products, making it an attractive therapy area for biosimilar competition.
The new wave of approved and launched biosimilars, mostly in oncology, are driving the changing tides. Earlier biosimilars have different uptake dynamics compared with the more recently launched biosimilars. Filgrastim biosimilars, first launched in 2013, only reached 39% volume attainment after two years on the market (Figure 1). In contrast, bevacizumab biosimilars, first launched in 2019, reached 42% volume attainment after only one year on the market. The bevacizumab biosimilars are projected to reach 60% in two years’ time, with greater savings and a more established market expected as a result. Factors affecting bevacizumab uptake include positive shifts in physicians’ attitudes, provider and patient education, and financial incentives. Regulatory bodies, such as the FDA, are encouraging innovation and competition among biologics and the development of biosimilars, which will continue to help raise awareness and uptake. These changes indicate a healthier competitive market is on the horizon, with originator manufacturers also pursuing competitive actions. For example, an originator company released an ‘authorized generic’ version of their product at an only slightly higher price than a biosimilar, leading to greater pricing pressures in the space.
With continued increases in biologics spending expected, the biosimilars market presents an opportunity for these system savings. In 2019, biologics comprised 43% of total U.S. medicine invoice spending, equating to $211 billion. Biologics spending has substantially increased since 2014, at a compound annual growth rate (CAGR) of 14.6%, which is considerably higher than the 1.6% CAGR for small molecules. Biosimilars and their originator products comprised $40 billion in spending in 2019; importantly, this spending was across several key therapy areas where further biosimilar entry could have the greatest impact. Looking forward, the immunology market — including the autoimmune market with blockbusters like adalimumab (Humira) — is almost only biologic products, making it an attractive therapy area for biosimilar competition.
The new wave of approved and launched biosimilars, mostly in oncology, are driving the changing tides. Earlier biosimilars have different uptake dynamics compared with the more recently launched biosimilars. Filgrastim biosimilars, first launched in 2013, only reached 39% volume attainment after two years on the market (Figure 1). In contrast, bevacizumab biosimilars, first launched in 2019, reached 42% volume attainment after only one year on the market. The bevacizumab biosimilars are projected to reach 60% in two years’ time, with greater savings and a more established market expected as a result. Factors affecting bevacizumab uptake include positive shifts in physicians’ attitudes, provider and patient education, and financial incentives. Regulatory bodies, such as the FDA, are encouraging innovation and competition among biologics and the development of biosimilars, which will continue to help raise awareness and uptake. These changes indicate a healthier competitive market is on the horizon, with originator manufacturers also pursuing competitive actions. For example, an originator company released an ‘authorized generic’ version of their product at an only slightly higher price than a biosimilar, leading to greater pricing pressures in the space.
Figure 1. Biosimilar share of volume since biosimilar launch
DDD = Defined daily dose
Taking a closer look at the uptake of bevacizumab, our analyses indicate the uptake of biosimilar products is highly heterogenous at the outlet level. This heterogeneity can likely be attributed to different priorities within each outlet, including financial support, logistics, patient management capabilities, and the physician’s confidence in the performance of new treatments for their patients. There are outlets nearly fully committed to biosimilars, and thus nearly all bevacizumab products in use are biosimilars. But more interestingly, approximately 80% of outlets are managing a combination of originator and biosimilar bevacizumab products, despite the potential logistical challenges of delivering the right drug to the right patient. For those outlets using both, healthcare providers decide who receives a particular drug based on various factors, such as insurance plan design, clinical status of the patient, and availability of products. Furthermore, across the top 100 highest-volume outlets for bevacizumab, there is significant variation in the proportion of biosimilars used – from none-at-all to only biosimilars. This indicates that these trends are not driven by a few large outlets.
The promise of the future biosimilar market is the potential for substantial system savings. As more biosimilar products reach the market, biosimilar spending is expected to reach $16–36 billion by 2024. Despite spending increases, savings are projected to potentially exceed $100 billion over the next five years (Figure 2). There is a wide range of possible savings — from $69 to $140 billion — pending alignment of incentives across different stakeholders, including physician buy-in and shrewd negotiations. It also remains to be seen what competitive actions will be taken by originator companies, and what dynamics will exist in specialty pharmacy biosimilar products — none of which have launched yet.
Figure 2. Biologic estimated savings from biosimilars at invoice prices
Although the systemic savings appear promising, there are still concerns when it comes to patient out-of-pocket spending. The prices for patients may still be very high, despite reductions for biosimilars vs. originators.
While biosimilars have a critical role to play in the health system, they are not the silver bullet and don’t make up for some of the imperfections in the system in terms of insurance design and incentives.
However, the continued sharing of real-world data by physicians who are commonly prescribing biosimilars will help to increase awareness, encourage wider use, and will likely play a key role in the future of the biosimilars market. In oncology, the uptake of biosimilars in real-world settings is already strong, and with the availability of multiple biosimilars on the horizon, there is great potential for patient-level savings. While there are wider challenges to overcome regarding patient-level prices, biosimilars show the potential to not only save money, but also clear the way for future breakthroughs to reach and benefit patients.
For more information on this topic, view the on-demand webinar – Are we seeing a biosimilars turnaround? – and download the report – Biosimilars in the United States 2020–2024 – all from the IQVIA Institute for Human Data Science.