Roche under pressure in US as Amgen/Allergan launch US cancer biosimilars

Amgen and Allergan have launched their cut-price biosimilar competitors to two big-selling cancer drugs from Roche in the US.

The companies said they had launched Mvasi and Kanjinti – biosimilars of Avastin (bevacizumab) and Herceptin (trastuzumab), respectively.

They said that the list price for both these drugs will be 15% lower than the reference products – Mvasi will be available at a wholesale cost of $677.4 per 100mg and $2,709.60 for a single dose vial.

Kanjinti will be available at $3,697.26 per 420 mg vial. This translates into an average selling price (ASP) at launch for Mvasi that is 12% below that for Avastin, while Kanjinti is discounted at 13% compared with Herceptin.

The wholesale price does not account for discounts and rebates and may be significantly higher than out-of-pocket costs for patients.

Out-of-pocket costs depend on insurance arrangements, Medicare and some commercial insurance firms will likely pay for the drugs based on ASP.

Together the originators of these two drugs generated sales of $5.8 billion in the US in 2018, and for years have formed the backbone of Roche’s drugs business.

Celltrion and Teva have also got a biosimilar of Roche’s other big cancer drug Rituxan (rituximab) approved in the US, and a launch is imminent at an undisclosed time following an agreement with the Swiss pharma.

Sales of Rituxan, known as MabThera in Europe, were $4.3 billion in the US last year – meaning that a sizable chunk of the $23 billion generated by Roche’s pharma division in the country is coming under threat from cheaper competitors.

It’s also almost a quarter of worldwide drug sales, which stood at just under $44 billion in 2018.

These “big three” drugs have also come under intense competition from biosimilars in Europe, where originators have less scope to build “patent thickets” to stave off cheaper competitors.

Amgen also has a biosimilar of AbbVie’s Humira (adalimumab) inflammatory diseases blockbuster approved in the US, but along with a gang of other competitors must wait until 2023 to launch it under a legal agreement with the originator.

Roche is pinning its hopes on a new generation of drugs to make up for the lost sales and its multiple sclerosis drug Ocrevus (ocrelizumab) is already a blockbuster after approval in March 2017.