- Roche faces biosimilar competition in the U.S. to its best-selling cancer drugs Herceptin and Avastin, after a court decision Thursday denied the Swiss pharma's request for an injunction to prevent low-cost versions from entering the market.
- Amgen and Allergan launched biosimilars of both medicines Thursday, becoming the first to challenge Roche commercially. Earlier this year, Roche estimated biosimilars to Herceptin, Avastin and a third top drug, Rituxan, would arrive in the second half of 2019.
- Roche is appealing the decision, according to court filings. Herceptin and Avastin are critically important to the Swiss pharma, bringing in about $14 billion in sales last year, or roughly 30% of its total sales.
With Amgen and Allergan's launch, Herceptin (trastuzumab) and Avastin (bevacizumab) are now the first cancer drugs to face biosimilar competition in the U.S.
The lower-cost versions will come cheaper than Roche's brand-name versions, with Amgen and Allergan setting the list price to each at 15% below that of the original biologics.
Other drugmakers have previously won Food and Drug Administration approval, yet gone months or even more than a year without launching due to ongoing litigation.
Mylan, for instance, was first to gain U.S. approval in December 2017 for a Herceptin copycat, inking a settlement with Roche earlier this year to establish an undisclosed entry date. Mylan then said it anticipated potentially being the first to launch in the U.S.
Amgen and Allergan received FDA approval for their Herceptin biosimilar, called Kanjinti, just last month. Despite being fifth to a regulatory OK, the biosimilar will beat the others to market after Amgen won a round in its legal battle with Roche.
Roche's Genentech unit filed motions on July 10 for a temporary restraining order and a preliminary injunction against Amgen. A U.S. district court judge denied those motions on July 18, effectively clearing the way for a commercial launch.
Amgen does not consider its launch to be "at risk," an industry term for commercial efforts under threat of litigation.
A trial over the Herceptin biosimilar is set for December, and one concerning the Avastin copycat is scheduled for July 2020, according to Amgen.
Pfizer, Teva and partner Celltrion, and Samsung Bioepis also have FDA-approved Herceptin biosimilars that have yet to launch in the U.S.
For Amgen, the speedy launch is validation for its biosimilar efforts, particularly after Kanjinti was rejected for approval by the FDA slightly more than a year ago.
Market entry of biosimilars will test Roche's preparations for competition to what for years have been its best-selling medicines.
"We are confident in our ability to offset the impact of biosimilars in the United States given the success of our new product launches and the positive readouts from our late-stage pipeline of innovative medicines," a Genentech spokesperson wrote in an emailed statement.
Still, Roche expects competition to eventually weigh on sales. That impact has already been partially realized for Herceptin elsewhere. Sales fell by 16% last year after biosimilars launched in mid-2018 for the European and Japanese markets.