The numbers don’t lie. Companies can profit greatly from the biosimilar business, especially if they get an early jump. Amgen released their 2021 earnings last week, and it tells a compelling story.
For fiscal year 2021, Amgen reportedly earned $2.17 billion globally for three marketed biosimilar products. A total of $1.3 billion was earned in the US alone–despite the fact that Amjevita®, its adalimumab biosimilar, will not launch until January 2023, and Amgen does not break out revenues separately for its rituximab biosimilar Riabni®. To put that into perspective, Amgen’s biosimilar sales now comprise slightly less than 10% of total pharmaceutical sales revenue, with considerably more to come. Amjevita, for instance, can easily boost this figure by $500 million to $1.5 billion by the end of 2023.
| Amgen Biosimilar Brand | Reference Product | US Sales | ROW Sales |
| Amjevita | Humira® | N/A* | $439 million |
| Mvasi® | Avastin® | $826 million | $340 million |
| Kanjinti® | Herceptin® | $479 million | $93 million |
| Totals | $1.30 billion | $0.87 billion |
Amgen’s biosimilar pipeline is very promising at the moment, with candidates brewing in the aflibercept, ustekinumab, and eculizumab categories—all of the multibillion-dollar kind.
It should not be lost that Amgen is also working to stave off sales losses in several other reference product categories: filgrastim and pegfilgrastim (sales both down approximately 25% from the previous year), epoetin (down 13%), and etanercept (down 11%). Amgen may also have competition to high-profile brands in the next couple of years (Prolia®/Xgeva®—denosumab to name a major one).
In other words, Amgen’s biosimilar investments can be considered both a new revenue boost or a hedge against sales declines of older brands. Either way, it is paying off handsomely.
Coherus Biosciences, on the other hand, have a single marketed product, the biosimilar Udenyca®, which earned $476 million in 2020 and $254 million through three quarters of 2021, holds an 18% share of the pegfilgrastim market. Although the total sales are down, this is still pretty solid, three years into launch, considering the competition that has joined the fray.
For a company of this type, $350 million in estimated annualized sales is funding research and preparation for commercialization of three other biosimilars, clinical study and FDA supplemental application for its pegfilgrastim on-body injector, and a new PD-1 branded product. Coherus’ on-body injector development is significant, as that can open the door to significantly more pegfilgrastim marketshare by competing directly with Neulasta OnPro®. And Coherus, too, will be vying for a share of the $16 billion Humira pie in July 2023. This seems to be pretty much how CEO Denny Lanfear CEO drew up his company’s playbook several years ago.
