Tony Hagen is senior managing editor for The Center for Biosimilars®.
Amgen described how a double-edged biosimilars sword has worked for and against the company's profit margin.
Biosimilars worked for and against Amgen in the year just ended, according to the company’s 2020 financials. Amgen saw competitors’ biosimilars continue to erode sales and profits for the company’s originator products, such as Enbrel (etanercept) and Neulasta (pegfilgrastim); however, Amgen’s bevacizumab (Mvasi) and trastuzumab (Kanjinti) biosimliars delivered strong results, prompting the company to cite them as key revenue drivers.
“We've played a lot of defense in biosimilars, and now as we're on offense, we're able to have a high quality of execution,” said Peter Griffith, Amgen’s executive vice president and chief financial officer, in an earnings call.
“We continue to see biosimilars as an extremely strong allocation of capital for us. The margins continue to be very competitive, and we're very confident in terms of allocating capital that category, and we'll continue to do that, and we think we've got some strong expertise there,” he said.
The company reported $541 million in fourth-quarter 2020 biosimilar sales, which were boosted by higher sales volume and offset by lower selling prices—partly the result of competition. Total revenues were up 7% to $6.6 billion for the fourth quarter vs the comparable 2019 quarter, and up 9%, to $25.4 billion, for the full year.
Although Enbrel (etanercept) does not face biosimilar competition in the United States, where it was initially approved in 1998 for the treatment of rheumatoid arthritis, it does have multiple overseas competitors, including 3 in Europe: Erelzi (Sandoz), Benepali (Samsung Bioepis), and Nepexto (Viatris).
Global Enbrel sales totaled $5 billion in 2020 ($4.86 billion in the United States), down 4% from 2019. Lower selling prices and the coronavirus 2019 (COVID-19) pandemic contributed to sales declines, Amgen said.
Sales of Neulasta (pegfilgrastim), an originator product, were down 19% in the fourth quarter and dropped 29% for the full year, owing to lower selling prices and increased biosimilar competition, the company said. Total Neulasta sales were $2.3 billion in 2020 (US sales, $2 billion) vs $3.2 billion in 2019. Those figures include sales of Neulasta Onpro, a wearable pegfilgrastim injector kit which Amgen said “continues to be the preferred choice for physicians and patients with a volume share of 54% in the (fourth) quarter.” The prophylactic quality of Onpro has contributed to its popularity during the COVID-19 pandemic.
Amgen said the average selling price for Neulasta in the United States was down 28% in the fourth quarter vs the fourth quarter of 2019. “In 2021, we expect the pricing and volume dynamics to continue as biosimilar competition increases,” the company said. In the United States, Amgen faces Neulasta competition from 4 brands: Fulphila (Viatris), Udenyca (Coherus Biosciences), Ziextenzo (Sandoz), and Nyvepria (Pfizer).
Other maturing Amgen originator products facing heavy biosimilar competition in the United States and abroad are Neupogen (filgrastim) and Epogen (epoetin alfa) which saw full year sales declines of 15% and 31%, respectively.
In terms of Amgen’s biosimilar offense, Mvasi generated $280 million in fourth quarter 2020 sales and $798 million for the full year. “In the United States, Mvasi became the leader of the bevacizumab segment in the fourth quarter, with an average share of $48%,” the company said. Sales were up 21% in the fourth quarter of 2020 vs the comparable 2019 quarter. Amgen predicted more launches of this product in international markets. Mvasi so far has little competition in the United States. It is 1 of 2 approved and launched bevacizumab biosimilars.
Kanjinti generated $158 million in fourth quarter 2020 sales and $567 million for all of 2020. By year’s end, the product held a 41% average share of the trastuzumab market; however, total sales of this product were down as gains in sales volume were offset by price declines caused by competition, among other factors. There are 4 other trastuzumab biosimilars on the United States market.
"Bevacizumab as a molecule is actually growing [in sales], whereas trastuzumab as a molecule is flat to declining," said Murdo Gordon, executive vice president of Amgen's Global Commercial Operations. "So, one thing that we're seeing in Mvasi is actually the number of [treatment] cycles of bevacizumab overall are growing. So [market] share in that molecule actually holds up quite well. We also have less competition. That's the other factor. So there is less competition for now in the bevacizumab molecule whereas with trastuzumab we have more competitors. And so I think going forward, you would see competitive dynamics shaping those 2 brands a little bit differently."
Another performer in Amgen’s biosimilar portfolio was Amgevita (adalimumab), which saw full year 2020 sales of $331 million, up 54% from $215 million in 2019, although lower selling prices offset the sales increase. Launched in 2018, “Amgevita continues to be the most-prescribed adalimumab biosimilar in Europe,” Amgen said. There are 7 other adalimumab biosimilars authorized for sale in the European Union. No adalimumab biosimilars are yet marketed in the United States.
No sales data were provided for Avsola (infliximab), which Amgen launched in the United States relatively recently, in July 2020. The company has hopes for another biosimilar, Riabni (rituximab), which launched in the United States in January 2021, and in an update on product development, Amgen said a phase 3 efficacy and safety trial was underway for its eculizumab biosimilar candidate (ABP 959). ABP 959 references Soliris, a blockbuster drug for paroxysmal nocturnal hemoglobinuria and atypical haemolytic uremic syndrome that garnered $4.06 billion in global 2020 sales, up from $3.95 billion the year before. Biosimilar competition for eculizumab in Europe is anticipated in 2022.
Amgen, in a settlement with Soliris manufacturer Alexion, has agreed to delay the US launch of ABP 959 until 2025.