Amgen Sees Biosimilar "Give and Take"

Biosimilar competition took a big bite out of revenues for Amgen, although the company’s own biosimilar portfolio notched impressive growth, according to Amgen’s first quarter 2020 earnings. The company said the coronavirus disease 2019 (COVID-19) pandemic has caused a decline in new patient starts for some of the company’s products.

“Due to the uncertainty related to the COVID-19 impact, we expect some degree of uncertainty in quarterly revenue and earnings over the year. We currently expect that we will see the greatest impact later in Q2, with stabilization and then partial recovery occurring during the second half of the year,” said Peter Griffith, executive vice president and chief financial officer, during the company’s earnings call.

Biosimilar Erosion

Amgen’s Neulasta (pegfilgrastim) sales declined 40%, to $609 million from $1 billion in the comparable year-ago quarter. There are 3 pegfilgrastim biosimilars on the US market: Ziextenzo, Udenyca, and Fulphila, by Sandoz, Coherus BioSciences, and Mylan/Biocon, respectively. Two of those were launched in 2019.

Neupogen (filgrastim) sales dropped to $65 million in the first quarter of 2020 from $73 million in the comparable year-ago quarter, an 11% decline. Neupogen has competition on the US market from the Pfizer/Hospira product Nivestym and Sandoz’ Zarxio, both biosimilars. Zarxio has been on the market since 2015.

Amgen’s epoetin alfa product (Epogen) had total sales of $155 million in the just-ended quarter, down from $219 million a year ago, representing a 29% decline. Marketed only in the United States, Epogen faces biosimilar competition from Pfizer/Hospira’s Retacrit, which launched in 2018.

The company reported first quarter 2020 sales of $1.2 billion for Enbrel (etanercept), roughly unchanged from $1.2 billion in the year-ago quarter. Amgen has so far managed to fend off biosimilar competition for Enbrel. Both Sandoz and Samsung Bioepis have FDA approvals for etanercept biosimilars but no announced launch dates. Sandoz has unsuccessfully litigated 2 key patents that expire in 2028 and 2029, respectively.

Biosimilar Growth

Although some of its products are seeing serious sales erosion from biosimilar competition, Amgen is pleased with its own biosimilar portfolio, said Murdo Gordon, executive vice president of global commercial operations. “We continue to see encouraging adoption rates in clinics, with hospital adoption accelerating. These biosimilars are increasingly valuable given the cost savings they provide,” he said.

The company’s bevacizumab (Mvasi) and trastuzumab (Kanjinti) biosimilars generated $234 million in global sales during the first quarter.

Globally, Mvasi had $115 million in total sales, up 37% from the fourth quarter of 2019. Kanjinti had $119 million in total sales, up 16 percent from a year ago.

In the United States, Mvasi had $108 million in sales in the first quarter, versus $79 million in the previous quarter. Kanjinti’s US sales were $96 million, up from $79 million the previous quarter.

Additionally, the US market shares for Mvasi and Kanjini were 33% and 27%, respectively.

“We're fortunate that we were early in the United States with both Mvasi and Kanjinti and able to establish a very strong foothold in the market,” said Gordon. Mvasi and Kanjinti were launched in the United States in July 2019.

Mvasi is a biosimilar for reference Avastin (bevacizumab) and is used to treat colorectal, lung, glioblastoma, kidney, cervical, and ovarian cancer. It is also used to treat age-related macular degeneration.

Kanjinti is a monocolonal antibody used to treat patients with HER2-postive breast cancer and stomach cancer. It is a biosimilar for reference Herceptin (trastuzumab).

In total, Amgen reported revenue of $6.2 billion for the first quarter, up 11% from the year-ago comparable quarter. Despite that success, uptake of some products, notably Xgeva (denosumab), is being affected by the pandemic, the company said. “Certain products like Xgeva may be impacted in the current environment due to disruptions in physician-patient interactions,” Gordon said.

Amgen’s Other Biosimilar Pursuits

Gordon expressed Amgen’s intentions to launch Avasola, their biosimilar for Remicade (infliximab), on the US market sometime later this year, but did not specify a date.

“That product will help strengthen what is already a strong immunotherapy portfolio for us, and will help us broaden that customer perspective,” said Gordon.

Additionally, Amgen has an FDA-approved adalimumab biosimilar (Amjevita) to AbbVie’s reference drug Humira. However, due to AbbVie’s current patent exclusivity, Amgen will have to wait until 2023 to release it on the US market.

Amjevita is marketed in Europe and earned $86 million in first quarter sales, up from $31 million in the year-ago quarter. It is the most prescribed biosimilar adalimumab in Europe.

To sum up the current status of biosimilars, Gordon said, “I do think that the biosimilar market is alive and well in the United States and functioning as you would hope free markets would.”