Amgen Biosimilars See Increased Sales as Reference Product Sales Erode

Despite sales decreases for its trastuzumab and bevacizumab biosimilars, Amgen’s first quarter (Q1) of 2022 revenues were up overall, including global increases for several biosimilars, according to the company’s earnings report.

The company accumulated $6.2 billion in total revenues, a 6% increase compared with Q1 2021 resulting from 2% growth in global product sales and increased revenue from Amgen’s manufacturing collaboration for COVID-19 drugs.

Biosimilar Performance

According to the report, Amgevita (adalimumab-atto) was the most prescribed adalimumab biosimilar throughout Europe. From Q1 2021 to Q1 2022, the biosimilar had increased year-over-year sales of 2%, caused by 16% volume growth. The increase in net sales was partially offset by foreign exchange impact and lower net selling price resulting from increased competition from other adalimumab biosimilars. In the European Union, there are 10 adalimumab biosimilars competing with the reference product (Humira).

Net sales for Mvasi (bevacizumab-awwb) decreased 17% year-over-year, which the company attributed to lower net selling price, partially offset by 13% volume growth. Mvasi is 1 of 3 bevacizumab biosimilars in the United States. The European Union has 7 bevacizumab biosimilars referencing Avastin including Mvasi. Amgen said that it expects that Mvasi’s net selling price and volume declines driven by increased competition will continue to erode.

Kanjinti (trastuzumab-anns) was the highest selling trastuzumab biosimilar in the United States, where it is 1 of 5 FDA-approved biosimilars for Herceptin. However, the global sales for the drug decreased 40% year-over-year due to the same reasons that sales for Mvasi decreased. In the European Union, there are 6 trastuzumab biosimilars approved for marketing.

Amgen combined the sales for Avsola (infliximab-axxq) and Riabni (rituximab-arrx) with Gensenta, Imlygic, Corlanor, and Bergamo into the “other products” category. The sales for this group increased by 18% between Q1 2021 and Q2 2022.

Reference Product Performance

Amgen reported that year-over-year net sales decreased by 7% and the year-over-year volume remained flat during Q1 2022 for Enbrel (etanercept). The company said this was due to declines in net price and inventory levels. Although Enbrel will not face any biosimilar competition in the United States until 2029, the drug is competing against 3 etanercept biosimilars in the European Union.

In the report, Amgen combined the sales for Neulasta (pegfilgrastim), Neupogen (filgrastim), and Epogen (epoetin alfa) with other “established products,” including Aranesp, Parsabiv, and Sensipar/Mimpara. The sales for these products amounted to $970 million during Q1 2022, representing a 12% year-over-year decrease. Neulasta, Neupogen, and Epogen all face biosimilar competition in the United States and European Union, and Amgen said that it expects that net price and volume erosion will continue.

Amgen’s Biosimilar Pipeline

Amgen updated investors on its 4 biosimilars in development, including Amgevita. Although the drug is marketed in Europe and approved by the FDA, the company is conducting a phase 3 study that will provide data to support an interchangeability designation in the United States.

If granted, pharmacists will be able to automatically switch out Humira for the biosimilars without needing to seek provider permission. Amgevita is anticipated to be the first adalimumab biosimilar to enter the US market in January 2023, where it will be marketed as Amjevita.

Additionally, phase 3 studies evaluating the safety and efficacy of biosimilars referencing Stelara (ustekinumab), Eylea (aflibercept), and Soliris (eculizumab) are in progress. The company is also conducted a phase 3 analysis to support interchangeability for its ustekinumab biosimilar (ABP 654). Data for the studies assessing ABP 938 (aflibercept biosimilar) and ABP 959 (eculizumab biosimilar) are expected to be completed in 2022.