Amgen Announces $19M in Q2 Revenue From Amjevita; Humira Down 26% in US

For half a year, Amjevita, Amgen’s adalimumab biosimilar, had the US market all to itself after it launched January 31, 2023. However, in the second quarter (Q2), the biosimilar only brought in $19 million in revenue.¹

The reference product, Humira, still had net revenues in the United States of $3.452 billion.²

Globally, sales for Amjevita and Amgevita—what the biosimilar is marketed as outside of the United States—had increased 29% year over year. Total global sales in Q2 were $150 million. Sales outside of the United States were $131 million in Q2 2023, up 12.9% over a year ago.

Sales in the United States were down 63% quarter over quarter driven by a drawdown in inventory levels following the inventory build to support the product’s launch, according to an Amgen press release.¹

In a year with as many as 9 adalimumab biosimilars expected to launch in the United States, Amjevita held a coveted spot because it had market exclusivity for 6 months before more competition hit (Table). And more competitors may be coming.

Teva Pharmaceuticals is pursuing its own adalimumab biosimilar with an eye on a 2024 launch as long as the company’s Iceland production site passes an inspection. Teva’s CEO, Richard Francis, told Reuters that despite the challenging market, he still sees launching another adalimumab as being worthwhile because the US biosimilars market is still evolving.³

After Amjevita, another 7 biosimilars launched. Currently, the only approved adalimumab biosimilar that has yet to launch is Abrilada from Pfizer. Among the competitors now on the market is Cyltezo, the only adalimumab biosimilar that has so far been granted interchangeability, which some experts expect will give Cyltezo an advantage because it can be substituted at the pharmacy.

A report from Cardinal Health found that more than 60% of surveyed providers only want to prescribe adalimumab biosimilars with the interchangeability designation.⁴ While Cyltezo is currently the only adalimumab biosimilar with the designation, Hadlima, Abrilada, and Yuflyma are expected to seek the designation. In addition, Alvotech is submitting its candidate, AVT02, to the FDA for approval as an interchangeable adalimumab biosimilar.

At the end of July, AbbVie, the maker of Humira, announced second-quarter financial results, including that global Humira net revenues were just over $4 billion, a decrease of 25.2% on a reported basis compared with the same quarter a year ago. In the United States, Humira’s net revenues were down 26.0%.

In comparison, risankizumab (Skyrizi) and upadacitinib (Rinvoq) global net revenues were up 50.4% and 55.1%, respectively, on a reported basis.

Richard A. Gonzalez, chair and CEO of AbbVie, noted that the company’s performance was driven “predominantly by our non-Humira business.” However, he noted in a conference call that the company is pleased with how well Humira is competing against biosimilar competition so far, reported FiercePharma.⁵

Amgen also reported sales decreases for 2 other biosimilars, bevacizumab-awwb (Mvasi) and trastuzumab-anns (Kanjinti). Year over year, Mvasi’s sales were down 19% and Kanjinti’s sales were down 41%, both driven by lower net selling. “Going forward, we expect continued net selling price erosion,” Amgen said about both products,1 driven by increased competition.

References

1. Amgen reports second quarter financial results. Press release. Amgen. August 3, 2023. Accessed August 7, 2023. https://www.amgen.com/newsroom/press-releases/2023/08/amgen-reports-second-quarter-financial-results

2. AbbVie reports second-quarter 2023 financial results. Press release. AbbVie. July 27, 2023. Accessed August 7, 2023. https://news.abbvie.com/news/press-releases/abbvie-reports-second-quarter-2023-financial-results.htm

3. Scheer S. Teva CEO says not too late to launch Humira biosimilar in 2024. Reuters. August 2, 2023. Accessed August 7, 2023. https://www.reuters.com/business/healthcare-pharmaceuticals/teva-pharm-ceo-not-too-late-launch-humira-biosimilar-2024-2023-08-02/

4. Jeremias S. Report: over 60% of providers plan to only prescribe interchangeable adalimumab biosimilars. The Center for Biosimilars®. February 23, 2023. Accessed August 7, 2023. https://www.centerforbiosimilars.com/view/report-over-60-of-providers-plan-to-only-prescribe-interchangeable-adalimumab-biosimilars

5. Becker Z. Despite big Q2 declines for Humira and Imbruvica, AbbVie still boosts earnings guidance. FiercePharma. July 27, 2023. Accessed August 7, 2023. https://www.fiercepharma.com/pharma/abbvie-optimistic-halfway-point-humiras-year-biosimilar-attacks-lowers-estimate-biosimilar