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

After about a decade in the biosimilars business, Amgen is among the top players in the burgeoning field. Next year, it's looking to really make its mark with the first U.S. biosim to AbbVie's megablockbuster Humira.

At the 2022 Biotechnology Innovation Organization (BIO) Convention, Amgen presented a preview of its annual trends in biosimilars report. In an interview, Amgen's Ian Thompson, senior vice president and general manager of business operations in the U.S., said that while Europe got off to a faster start in biosimilars, it's fair to say that “the U.S. has caught up and arguably overtaken [Europe] in the last few years.”

In the eight years since Europe’s first approved biosim in 2008, 15 received approval there. In contrast, in the eight years after the first U.S. biosimilar launch (2015), 36 have been approved and 22 have launched, Amgen's trends report says.

Looking forward, Amgen is set to launch the first Humira biosimilar in late January 2023. Over the subsequent months, many other biosimilar players are slated to reach the market through their own settlements with AbbVie. When those competitors launch, Thompson says the Humira biosimilar market will resemble the competition in innovative medicines as each competitor looks to highlight their own advantages.

For Amgen, the company plans to focus on education, the patient experience and real-world evidence, Thompson said. Patients, payers and providers need to understand why they would move from the branded medicine to a newer biosimilar, so Amgen plans to ensure its educational sites are up and running promptly. It also plans to answer any questions by staffing company representatives at call centers.

Amgen has been selling innovative and biologic drugs for many years, so the company has the know-how to succeed in biosims, Thompson said. Over the span of about a decade in biosims, the company has invested "well over" $2 billion in the field, resulting in a portfolio of 11 copycat biologics. Five have received FDA approval, and four are already commercially available.

While it’s impossible to know exactly how biosimilar uptake will play out, Amgen believes the medicines will deliver cost savings to the healthcare ecosystem. Oncology biosimilars have already delivered some savings, Thompson said.

Thanks to a 2017 settlement, Amgen will have a head start with its Humira biosimilar. The company is set to launch in late January, and it will be followed by other biosimilars next July, September and November, according to Cardinal Health.