Amgen to Launch First Humira Biosimilar in the U.S. as 'Blockbuster' Drug Faces Market Erosion

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"Humira," the "King of Drugs," is about to end its market exclusivity period. A large number of pharmaceutical companies, including Amgen, Organon, and Boehringer Ingelheim, are eagerly eyeing the market and have successively launched plans for biosimilar drugs.

Latest news shows that in January 2023, Amgen will launch the first biosimilar of AbbVie's Humira in the U.S. market.

About a decade after embarking on its biosimilar business, Amgen has become one of the leading players in this emerging field. In 2023, the company will reach a pivotal moment — launching the first biosimilar to AbbVie’s flagship product Humira (adalimumab) in the U.S. market.

Recently, at the 2022 Biotechnology Innovation Organization (BIO) conference, Amgen previewed its annual trends report on biosimilars. Ian Thompson, Senior Vice President and General Manager of U.S. Business Operations, stated in an interview that while Europe initially led the way in biosimilars, it is fair to say that the U.S. has caught up over the past few years and arguably surpassed Europe.

Eight years after the first biosimilar was approved in Europe in 2008, 15 biosimilars have been approved. In contrast, Amgen's trend report shows that in the eight years following the launch of the first biosimilar in the United States (in 2015), 36 biosimilars have been approved, with 22 already on the market.

Looking ahead, Amgen will be the first to launch its Humira biosimilar in the U.S. market by the end of January 2023. In the following months, many other companies will successively bring their respective Humira biosimilars to the market through settlement agreements reached with AbbVie. Ian Thompson pointed out that when these competitors enter the market, the competition among Humira biosimilars will resemble that of innovative drugs, as each competitor will aim to highlight the advantages of their own products.

Ian Thompson pointed out that for Amgen, the company plans to focus on education, patient experience, and real-world evidence. Patients, payers, and providers need to understand why they would switch from a brand-name drug to a new biosimilar, so Amgen plans to ensure its educational website is quickly established and operational. The company also plans to have company representatives available at call centers to answer any questions.

Ian Thompson stated that Amgen has been selling innovative biologics for many years, so the company has the know-how to succeed in biosimilars. About a decade after entering the biosimilar space, the company has invested "well over" $2 billion, building a portfolio of 11 biosimilars. Five of these have received FDA approval in the U.S., and four are already on the market.

While it is impossible to know exactly how the market will accept biosimilars, Amgen believes that these drugs will bring cost savings to the healthcare ecosystem. Ian Thompson pointed out that oncology biosimilars have already saved a significant amount of healthcare expenses.

Thanks to a settlement agreement reached in 2017, Amgen will gain a leading advantage in the launch of Humira biosimilars. According to Cardinal Health, the company’s product is scheduled to be launched by the end of January, while biosimilars from other companies will follow in July, September, and November next year.

At that time, what changes will occur in the market landscape?

Reference Source: As biosimilars gain steam, Amgen exec lays out its Humira copycat plans