The Amgen Biosimilars Trend Report found that competition is lowering prices of biosimilars but the largest PBMs are inconsistent in their management of these products.
Payers are looking to biosimilars as a way to manage costs, but the three largest PBMs have taken varying positions on formulary placement of biosimilars, according to Amgen’s 2022 Biosimilar Trend Report. The report highlights the example of Janssen’s anti-inflammatory Remicade (infliximab) for Crohn’s and ulcerative colitis, which has three available biosimilars. CVS Caremark includes Remicade as the preferred product and does not include the biosimilars, while Express includes the biosimilar Inflectra from Pfizer as the preferred product and OptumRx includes two biosimilars Inflectra and Avsola from Amgen as preferred
At the same time, all three PBMs include Ruxience, a biosimilar of Rituxan (rituximab) to treat rheumatoid arthritis, as the preferred product. All three have excluded the reference product and two other biosimilars: Truxima and Riabni.
Overall, the Amgen report said, the average sales price of both biosimilars and their reference products have decreased over time. In the United States, 39 biosimilar products have been approved and 22 have been launched. Since 2015 when the first U.S. biosimilar was launched, the prices of have decreased at a negative compound annual growth rate (CAGR) of -9% to -24%. The downward trend in pricing has impacted references products as well, which decreased at a negative CAGR of -4% to -21%. Over the past six years, the drug spend for classes with biosimilar competition has been reduced by $21 billion.
“As the number of treatment choices increases for a particular disease or condition, manufacturers may be incentivized to lower the prices of their products to remain competitive,” the report authors said.
One product that demonstrates the impact of biosimilars is Genentech’s Herceptin (trastuzumab), which is used to treat patients with HER2-positive breast cancer and gastric cancer. Five Herceptin biosimilars have been launched since 2019; the first was Amgen’s Kanjinti, which launched at a wholesale acquisition cost that was 15% less than Herceptin and an average sales price that was 13% less. During this time, Herceptin’s price declined 19%, and three years after the launched of the first Herceptin biosimilars, the biosimilars now account for an 80% market share of all trastuzumab products. The cumulative savings in drug spend for trastuzumab from the third quarter 2019 to second quarter 2022 is estimated to be $5.3 billion.
Uptake of other biosimilars has been increasing, also taking market share from the reference products. For therapeutic areas with biosimilars launched in the last three years, the average share was 75%. For therapeutic areas with biosimilars launched prior to 2019, the average share after three years was 39%.
The number of biosimilar approvals and launched dipped in 2020 and 2021 because of the COVID-19 pandemic, but Amgen researchers expect new approvals and launches to increase. Among the launches to come in 2023 are the seven that reference AbbVie’s rheumatoid arthritis therapy, Humira (adulimumab). The first biosimilar, Amgen’s Amjevita, is expected to launch in January 2023. The others are expected to launch in the second half of the year include: the Merck’s Hadlima, Boehringer Ingelheim’s Cyltezo, Coherus BioSciences’ Yusimry, Viatris’ Hulio, Sandoz’ Hyrimoz, and Pfizer’s Abrilada.
In the European Union where Humira biosimilars began to be launched in 2019, the biosimilar adulimumab product have taken market share from Humira. For example, Amjevita, which launched first in the EU, now has a 20% share of the market, followed by Hyrimoz, which has 19% of the market.