Patent expiry is an issue that all successful drug makers must face eventually, and Roche is set for a particularly hazardous year on this front. Three of the Swiss company's cancer blockbusters will be opened up to cut-price competition in the US this year, though the financial impact will not be quite as painful as it could be.
This is because Avastin and Herceptin are biologics, and the speed at which biosimilars will be adopted is very hard to gauge. Even launch dates remain hard to know in this space: copycat versions of Herceptin are set to appear around mid-year under a settlement forged between Mylan and Roche, but legal wrangling over Avastin could well keep rivals off the market until well into 2020.
Instead, it is probably competition to another major Roche product, Rituxan, that will be felt most keenly by the company this year. Key patents covering the blood cancer treatment lapsed at the end of 2018 in the US, and if swift biosimilar uptake in Europe is anything to go by, the entrance of rivals in the US will be painful. Teva and Celltrion received approval for Truxima last year and are expected to launch at some point in the first half of 2019 under the terms of a deal with Roche, though no details have been disclosed.
Rituxan sold $4.4bn in the US last year, almost as much as Avastin and Herceptin combined. So while these two antibodies might technically be 2019 patent losses, in terms of financial impact, the focus this year will be on Rituxan.
|Biggest US patent expiries of 2019|
|Product||Company||US total lifetime sales ($bn)||2018 US sales ($bn)|
|Invega Sustenna||Johnson & Johnson||16.3||1.5|
Amgen is the lead contender for launching an Avastin biosimilar, though court cases are ongoing and hearings are scheduled for later this year and in 2020. Thus a launch this year is not widely expected.
The vagaries of biosimilar development mean that cut-price competition for Bristol-Myers Squibb's autoimmune therapy Orencia is also unlikely to emerge anytime soon, in the US at least. The only active project was being pursued by Momenta, but the biotech’s exit from biosimilars left work in limbo.
One US biosimilar market to watch this year will be Neulasta; although patents expired some years ago regulatory hold-ups have delayed launch until the end of 2018. Mylan and others are hoping to crack this blockbuster market in earnest this year.
The other key Roche product to fall this year is Tarceva, an EGFR kinase inhibitor, which is already a shadow of its former self thanks to newer and better lung cancer drugs. Sales have been in decline for the last four years, which might actually lessen the competitive threat as the product is presumably losing its appeal for generic firms.
And finally J&J will see exclusivity lapse for its hugely successful sustained release anti-psychotic, Invega Sustenna. The product is injected once a month, though a new version administered once every three months, Invega Trinza, was launched more recently in 2015, which will protect sales of the franchise somewhat.
However the world of biologics will be where the big fights are this year, between originators and challengers. With many expecting the biosimilar environment in the US to gradually start improving, demand for the new versions of Rituxan, Herceptin and Neulasta will be tracked with interest.