Tony Hagen is senior managing editor for The Center for Biosimilars®.
Amgen said its sales results for Mvasi (bevacizumab) and Kanjinti (trastuzumab) give it confidence that the US market for biosimilars is more viable than generally perceived.
Being in the position of both selling and competing with biosimilars, Amgen had mixed financial results to report for the business quarter just ended. The company saw significant sales increases for its newly launched biosimilars, but its established originator brands saw continued revenue erosion because of biosimilar rivals.
Amgen’s follow-on Onpro pegfilgrastim injector kit maintained a dominant share of the pegfilgrastim market, although the company’s originator pegfilgrastim product (Neulasta) suffered a sales decline. The same was true for Amgen’s reference etanercept (Enbrel), which faces competition in Europe but not in the United States.
Overall, the company said that it anticipates rising competition from biosimilars for both its originator brands and its biosimilars. Amgen also provided updates on ustekinumab and rituximab biosimilar candidates it has in development.
An "Efficient" Market
The company remarked in an investor call about the results that whereas the US market was previously discouraging for biosimilars developers, the company’s own recent experience has proved that it is possible to succeed with biosimilars in this country.
“A lot of people question whether we had an efficient functioning biosimilar market in the United States because I think they were overinterpreting some of the early biosimilar launches,” Murdo Gordon, executive vice president for Global Commercial Operations, said. “I think what you can see now is that we have an efficient market….When there is clear value on the table, health care systems, providers, and payers are able to capitalize on it, and that’s what’s driving, of course, the uptake of our biosimilars.”
Ironically, he said, the company has seen how biosimilars have captured market share from its own reference products and learned from that how to push its biosimilars through sales channels with success.
However, usage patterns have been different from what was anticipated. “Of the [purchasers] that have opened up biosimilar usage, initially we thought they might be using biosimilars for new patients going forward, but we’ve actually seen them use our biosimilars both for new patients and switching patients, who are in the midcourse of treatment, to biosimilars as well.”
In oncology, significant absorption of biosimilars has been observed both within and outside the 340B Drug Pricing Program, which makes discounted drugs available to a broad swath of the US hospital network, Gordon said. The same has not been true for inflammation biosimilars, whether self-administered or infused.
At Amgen, third-quarter biosimilar revenues were $480 million, driven by market share growth for Mvasi (bevacizumab) and Kanjinti (trastuzumab). These were cited as chief contributors to the company’s 12% increase in global revenues, to $6.4 billion, compared with the third quarter of 2019.
Mvasi sales were $231 million vs the third quarter of 2019, up 34%, and the product now has a 44% share of the US market, although competition led to a decline in the selling price for this product and the company said it anticipates biosimilar competition.
Kanjinti sales were $167 million, up 36%, also since the third quarter of 2019, and the US market share for the trastuzumab market was 34%, Amgen said.
“Moving forward, we expect volume growth will be offset by a decline in net selling price due to increased competition,” the company said in a statement.
The Neulasta Success Story
On the originator product side, Neulasta Onpro (follow-on) held onto a 55% market share, but Neulasta (originator) sales declined 22% since the third quarter last year, caused by biosimilar competition. The company said Neulasta’s average selling price in the United States declined 19% since this time last year and 6% over the quarter just ended.
Amgen also is the reference producer for filgrastim (Neupogen), which has seen a 19% decline by sales volume since the third quarter last year. A 1-year decline for epoetin alfa (Epogen) sales was noted (31%), caused by sales volume declines and a lower net selling price, Amgen said.
Sales of Enbrel declined 3% compared with the third quarter last year, and the company said conditions caused by coronavirus disease 2019 contributed to that reduction; however, there was no change in the net selling price for the product.
The company’s adalimumab (Amgevita) biosimilar saw a 31% increase in sales compared with the third quarter of 2019.
“Amgevita continues to be the most prescribed adalimumab biosimilar in Europe,” Amgen said.
In its development pipeline, the company’s ustekinumab biosimilar candidate (ABP 654) has advanced to the phase 3 trial level and its rituximab biosimilar (ABP 798) is under review for approval by the FDA, with a scheduled action date of December 19, 2020.
In a recent assessment of the US biosimilars market, Amgen looked at uptake for multiple brands of biosimilars and original products. Details of that report can be found here.
In addition, a discussion of the report and its implications is available in an interview with Amgen’s director of marketing and team leader for global biosimilar launches, Chad Pettit, MBA.