Manufacturers See the Upside of Their Biosimilars in 2021 Bottom Lines

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 BrandReference ProductUS SalesROW Sales
AmjevitaHumira®N/A*$439 million
Mvasi®Avastin®$826 million$340 million
Kanjinti®Herceptin®$479 million$93 million
Totals$1.30 billion$0.87 billion
ROW = Rest of World. *To launch January 2023.

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.

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