Amgen made two major announcements Tuesday by launching its Humira biosimilar and releasing its most recent quarterly earnings report.
Amjevita, the first biosimilar to AbbVie’s blockbuster drug Humira, is now available in the U.S. at two different price points. Amjevita is available at a list price 55% below the current Humira list price as well as at a list price 5% below the Humira list price.
Like Humira, Amjevita is citrate-free and available in a prefilled syringe and autoinjector presentations to assist patients with dosing. The treatment is approved for seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis in adults, moderate-to-severe chronic plaque psoriasis in adults and moderate-to-severe Crohn’s disease in adults, among other conditions.
“With today’s announcement, AMJEVITA is the first U.S. biosimilar to Humira®, a medicine used by more than a million patients living with certain serious inflammatory diseases,” Murdo Gordon, EVP of global commercial operations at Amgen, said in a statement. “With our track record of developing and manufacturing biologics and decades of experience in inflammation, Amgen is uniquely equipped to supply this biosimilar medicine while reducing costs.”
Amgen has long been a supporter of the potential of biosimilars, with 11 biosimilar medicines in market or currently under development, according to a company press release.
The pharma giant also released a report in the fall of 2022 that found biosimilars saved the healthcare system $21 billion over the past six years. In its report, Amgen also said there is a possibility that there will be seven or more Humira biosimilar launches in 2023, threatening the $114 billion Humira generated with its main patent protections since 2016.
While the introduction of Humira biosimilars is a blow to AbbVie, a 2022 forecast by Evaluate Pharma projected the company will be the largest pharmaceutical company by prescription drug sales in 2028.
In addition to the Amjevita news, Amgen released its Q4 2022 earnings report, which excluded contributions related to the announced $28.5 billion acquisition of Horizon Therapeutics.
For the quarter, Amgen reported flat revenues of $6.8 billion as an increase in product sales was offset by lower Other Revenue from its COVID-19 manufacturing collaboration. Total revenues inched up 1% to $26.3 billion for the full-year, driven by an increase in both product sales and volume.
Though Amgen’s earnings per share (EPS) decreased 11% during the quarter, its EPS increased 18% during 2022. The company’s free cash flow for the full-year also increased from $8.4 billion in 2021 to $8.8 billion in 2022.
Looking forward, Amgen projected total revenues between $26 billion to $27.2 billion, along with an EPS in the range of $13.16 to $14.41.
“We executed effectively in 2022, delivering strong volume growth, advancing numerous first-in-class medicines in our pipeline, and staying on track to achieve our long-term growth objectives,” Amgen CEO Robert Bradway said in a statement. “The announced acquisition of Horizon Therapeutics, which we expect to complete in the first half of this year, represents a compelling opportunity to serve more patients and strengthen our growth profile.”
