Amgen Q1 2021: Biosimilars Show Strong Growth as AMG510 (Sotorasib) Nears Regulatory Decision

On April 27, Amgen announced its first-quarter 2021 results, with net sales of $5.9 billion (-4%), representing a slight decline compared to the same period last year, primarily due to the impact of COVID-19.

Despite a 5% year-over-year decline in product sales, certain products still achieved double-digit growth, including Repatha (evolocumab), Prolia (denosumab), and the biosimilars MVASI (bevacizumab) and KANJINTI (trastuzumab).

Although sales of Enbrel (etanercept), a drug for treating autoimmune diseases such as rheumatoid arthritis, decreased by 20% compared to the first quarter of last year, it remained Amgen’s top-selling product, reaching $924 million. The osteoporosis drug Prolia (denosumab) grew by 16% to $758 million, making it one of Amgen’s pillar products. Sales of XGEVA, developed for indications including bone metastases from solid tumors and giant cell tumor of bone, amounted to $468 million.

Sales of the novel lipid-lowering drug REPATHA (evolocumab) increased by 25% year-over-year to $286 million, primarily driven by a 36% increase in sales volume.

The most notable focus on Amgen is undoubtedly every move of its KRAS inhibitor, LUMAKRAS™ (sotorasib). According to Amgen’s financial report, marketing applications have been submitted to regulatory authorities in eight countries. Sotorasib has been granted Priority Review by the FDA, with a PDUFA date set for August 16, 2021.