Amgen CEO Touts Potential for Doubling in Biosimilar Revenue

Excitement is building at Amgen as the year 2023 draws closer and the company gets ready to launch Amjevita, its biosimilar version of adalimumab, referencing the long-reining reference product Humira, an immunosuppressive product that had $20 billion in sales in 2020.

Adalimumab is used for the treatment of multiple inflammatory conditions, including arthritis, Crohn disease, ulcerative colitis, ankylosing spondylitis, plaque psoriasis, and others.

In 2021, Amgen’s biosimilar portfolio was generating annual revenues on the order of $2 billion, but with Amjevita and 6 other biosimilars in the pipeline, those revenues could “more than double” through 2030, Amgen Chairman and CEO Robert Bradway stated at the 2022 JP Morgan Healthcare Conference, held this month.

Amjevita will launch in January 2023, giving it at least a half-year head start on half-a-dozen other adalimumab biosimilars scheduled to start entering the market in June 2023. There are no adalimumab biosimilars on the market in the United States, and Amjevita will be the first, unless other contenders are able to break through innovator company AbbVie’s formidable patent barrier protecting Humira’s exclusivity. Each of the entrants scheduled so far has settled with AbbVie out of court on market timing and royalty compensation.

Bradway also described optimism for other biosimilar launches anticipated to occur shortly after Amjevita, including biosimilars for ustekinumab (Stelara), an immunosuppressive drug for plaque psoriasis and psoriatic arthritis; aflibercept (Eylea), an ophthalmology drug for age-related macular degeneration, macular edema, and diabetic retinopathy; and eculizumab (Soliris), an immunosuppressive drug used in the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

Currently, Amgen has 4 oncology-centered biosimilars on the market. These include trastuzumab (Kanjinti), bevacizumab (Mvasi), infliximab (Avsola), and rituximab (Riabni). These reference Herceptin, Avastin, Remicade, and Rituxan, respectively.

Bradway said these and the anticipated launches of pipeline products, including Amjevita, which is FDA approved, would target 11 innovator or reference products in total that by themselves generate $86 billion in annual revenue.

“Clearly, we see this as an attractive franchise from the revenue standpoint,” he said.

Humira was launched in 2002, making it 20 years of exclusivity so far for AbbVie, which has raked in at least $170 billion in global revenues during that time, according to a recent congressional investigation.

Adalimumab biosimilars have been making inroads into AbbVie's Humira revenues in the European Union, where sharp declines in Humira revenues have been observed, and in Canada, recently a push by the Canadian public health authorities has put 2 new adalimumab products on the radar for health care consumers in just the past month: Yuflyma (Celltrion Healthcare) and Simlandi (Alvotech).