Here Come the Oncology Biosimilars in the US: How Low Will Prices Go?

Regulatory NewsRegulatory News | 16 August 2019 |  By 

A quick look at biopharma’s top-selling drugs (including forecasted sales through 2024) reveals a trio of biologic cancer treatments that have been marketed since 1997 and will likely bring in a cumulative total of more than $300 billion.

But biosimilar competition for Roche’s Herceptin (trastuzumab), Avastin (bevacizumab) and Rituxan (rituximab) is now ready to launch in the US, and Bernstein biopharma analyst Ronny Gal said in a report issued Friday that prices overall “are likely to decline by 70% in five years.”

The prediction comes as last month, Amgen and Allergan said they would launch Mvasi (bevacizumab-awwb) and Kanjinti (trastuzumab-anns) with list prices 15% lower than their reference products, and Mvasi priced 12% below the current Avastin Average Selling Price (ASP) and Kanjinti priced 13% below the current Herceptin ASP.

But Kanjinti will see competition from four other trastuzumab biosimilars approved by FDA. And unlike Amgen, which launched at-risk (and will not see its sales halted for now), the other companies have settled with Roche and likely will not launch until late 2019 or 2020, according to Gal.

“Hypothetically, price can go down 90%+ given the higher starting point of US prices,” Gal wrote in reference to trastuzumab. “With five competitors, market price could crash, but the companies involved in the first wave are all pretty sophisticated and the buyers are fragmented.”

Another positive for both Mvasi and Kanjinti is that United Healthcare recently announced that as of 1 October, “Preferred product language will be added as follows: Use of Mvasi (bevacizumab-awwb) prior to the use of Avastin and other bevacizumab biosimilar products. Use of Kanjinti (trastuzumab-anns) prior to the use of Herceptin and other trastuzumab biosimilar.”

Meanwhile, Pfizer said it will launch its bevacizumab biosimilar, known as Zirabev, in the fourth quarter of this year. And Gal predicts that as many as four bevacizumab biosimilars could launch in the US by 2022, and that, “Pricing should hold better than the Herceptin market given fewer competitors and we expect the biosimilar to be priced at 55% discount to the pre-biosimilar price in 2024.”

As far as the rituximab biosimilars, two have been approved by FDA, and Gal expects they will launch in late 2019 and early 2020, with the potential for a third competitor by the end of 2020. He also predicts that the price of Rituxan will decline by 50% by 2024.

But biosimilars will face obstacles following their launches, with difficulties gaining preferred positions with payers and some not being approved for all the same indications as their reference products.

Europe may also serve as an indicator of what’s to come in the US for these three. For Herceptin, Gal predicts eight to 10 biosimilar competitors will eventually hit EU markets and pricing “will gradually decline to ~20% of brand price pre-biosimilars.” He also predicts that for rituximab in the EU, there will be “gradual decline to ~30% of pre-biosimilars price by 2024 as additional entrants force the duopoly prices lower.”


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy