Amgen Reports Double-Edged Biosimilars Results

Amgen has a hand in both originator products and biosimilar products, so as biosimilars gained traction in the United States over the second quarter, Amgen saw an ebb and flow in its revenue picture.

Overall, the company was able to report a 6% global increase in its product sales ($6.2 billion) compared with the second quarter of 2019, and its bevacizumab (Mvasi) and trastuzumab (Kanjinti) biosimilars played a notable role in that achievement; however, there was a chipping away that Amgen said could be attributed to the coronavirus disease 2019 (COVID-19) and biosimilar and generic competition.

COVID-19 was a major culprit working against the company’s struggles to boost revenues, Amgen said. Physicians have been unable to meet with patients, and as a result there have been delays in diagnosis and treatment. Inventory practices by companies looking to brace themselves against supply chain issues and demand fluctuations have also been a characteristic of the drug portfolio battering at Amgen and other companies.

“Sales of negatively affected products fell most early in the second quarter, with sales beginning to recover in the latter weeks of the quarter. As the quarter progressed, our teams increasingly responded to customer needs via remote interactions and also identified innovative solutions to support the delivery of patient care,” Amgen said.

Enbrel Holds Its Own

Amgen’s etanercept blockbuster (Enbrel) clocked an important victory against biosimilars in the second quarter when the US Court of Appeals for the Federal Circuit upheld the validity of 2 Enbrel patents that had been challenged by Sandoz, which wants to bring a biosimilar etanercept (Erelzi) to market. Amgen is still duking it out with Samsung Bioepis, which is trying to get the Eticovo etanercept biosimilar into the marketplace. Assuming status quo, there may not be an etanercept biosimilar on the market until 2029.

Nevertheless, for Enbrel, which has the whole US etanercept market to itself, it was not a great quarter. Sales dipped 9% year-over-year owing to competition from other quarters, lower growth of the rheumatology treatment market because of COVID-19, and a decline in new patients. US sales of Enbrel were $1.21 billion in the quarter. Amgen reported total Enbrel sales of $1.25 billion for the second quarter and $1.36 billion for the comparable year-ago period.

Pfizer holds the rights to sales of Enbrel in Europe and other markets outside the United States, where biosimilars have had market access, and earlier this week Pfizer reported a 16% drop in core revenues for the product.

Mvasi and Kanjinti biosimilars were each launched in 2019 and their sales appeared to be on the upward trajectory, according to the Amgen report. Kanjinti brought in $101 million in US sales for the quarter just ended, or a total of $123 million, versus $30 million in the second quarter of last year. The biosimilar commands a 32% share of the US market for trastuzumab.

Amgen sounded a cautionary note with this information. “The trastuzumab market has become increasingly competitive,” it said, noting the launch of 4 biosimilars in the US market this year, 3 of which were trastuzumabs: Ontruzant (Samsung Bioepis), Herzuma (Celltrion/Teva), and Trazimera (Pfizer).

Mvasi registered $149 million in US revenues for the just ended quarter, $172 total, and nothing for the second quarter of 2019. “Going forward, we expect increased competition in the United States, given the launch of a competing biosimilar earlier this year,” Amgen wrote. Mvasi ended the second quarter with a 39% share of the bevacizumab market in the United States.

Three Aging Blockbusters

The company also reported on the progress for 3 of its aging blockbuster originator products, each of now shares the market with biosimilars: Sales dropped 28% for Neulasta (pegfilgrastim), 35% for Neupogen (filgrastim), and 28% for Epogen (epoetin alfa). The respective dollar figures for total second-quarter sales were $520 million, $28 million, and $161 million.

Biosimilars were chiefly blamed for the decline in Neulasta sales, cutting into “net selling price and unit demand” although the company said National Comprehensive Cancer Network guideline revisions that recommended increase use of long-acting granulocyte colony-stimulating factors (G-CSF) helped to counter the decline in unit sales volume.

Further, the Neulasta Onpro wearable injector kit has demonstrated its value in the COVID-19 home-based care environment, Amgen said. “Within the long-acting G-CSF segment, Neulasta Onpro continues to be the preferred choice for physicians and patients, and [market] share increased to 58% this quarter. Onpro provides a unique value proposition during the pandemic as it allows patients to receive their G-CSF treatment without having to return to their doctor's office or other site of care for administration.”

The company said research and development expenses as a subset of operating expenses increased 3% in part because of higher investment in biosimilar development programs.

Big drivers in the revenue increase this quarter were apremilast (Otezla; $561 million), for psoriasis and psoriatic arthritis, and evolocumab (Repatha; $200 million), for hyperlipidemia, or high blood fat (lipids) control.