Amgen Biosimilar Report: Marketplace Poised for Growth

Biosimilars are helping to reduce healthcare costs and drug spend. They launch with a wholesale acquisition cost (WAC) that is up to 37% less than the reference products’ WAC. Additionally, average sales prices are declining for both reference products and biosimilars, according to a preview of Amgen’s recent Biosimilars Report. The full report will be released in the third quarter of 2022.

The report also found that the cumulative savings in drug spend for classes with biosimilars is estimated to have been $18 billion over the past six years.

Jen Norton

"Our 2022 Trends in Biosimilars Report Preview found that the marketplace with biosimilars is well-established and growing across multiple therapeutic areas," Jen Norton, vice president, head of U.S value & access, Amgen, told Formulary Watch. "This is good news for patients, their physicians and payers, as the successful adoption of biosimilars has increased competition and generally lowered treatment costs associated with biologic medicines.”

Uptake of biosimilars is increasing as well. For therapeutic areas with biosimilars launched in the last three years, the average market share was 74%, and the report found that first-to-launch biosimilars tend to capture a great portion of the segment compared with those that launch later.

After a slowdown of approvals in 2020 and 2021 likely due to the COVID-19 pandemic, biosimilar approvals are expected to be similar to pre-pandemic levels, Amgen officials said. The number of development programs has increased from 77 in March 2019 to 97 in December 2021.

As of May 2022, 36 biosimilars have been approved and 21 have launched for 11 reference products. Next year, a new wave of biosimilars is expected. Throughout 2023, seven approved biosimilars of AbbVie’s anti-inflammatory drug Humira (adalimumab) will be launched.

The first to launch is Amgen’s Amjevita, scheduled for launch by Jan. 31, 2023. The FDA approved Amjevita (adalimumab-atto) in September 2016 for seven inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, adult Crohn's disease and ulcerative colitis. It was launched in Europe in 2018.

Amgen is enrolling patients into a phase 3 clinical trial that would support an interchangeable designation, which would allow substitution at the pharmacy level. To be a biosimilar that is interchangeable to an approved reference biologic, companies must demonstrate there are no clinically meaningful differences in terms of safety, potency and purity.

Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), which was approved by the FDA on Oct. 15, 2021, already has an interchangeable designation. It is expected to launch July 1, 2023.

Related:FDA Approves First Interchangeable Biosimilar of Humira

Pfizer in February 2022 submitted a supplemental biologics license application for its biosimilar Abrilada (adalimumab-afzb). It was approved by the FDA in 2019. A decision on interchangeability is expected in the fourth quarter of 2022. Abrilada could launch as early as July 2023, according to Pfizer’s most recent financial release.

Other Humira biosimilars expected to launch next year include

• Samsung Bioepis/Merck’s Hadlima, approved July 2019; expected to launch June 30, 2023,
• Coherus BioSciences’ Yusimry, approved December 2021; expected to launch July 1, 2023,
• Mylan’s Hulio, approved July 2020; expected to launch July 31, 2023
• Sandoz’ Hyrimoz, approved October 2018; expected to launch Sept. 30, 2023.

Amgen’s report indicates two additional Humira biosimilars that are not yet approved could also launch next year: Fresenius Kabi’s Idacio and Celltrion’s Yuflyma.