French court overturns €444m fine for Novartis, Roche
Two and a half years after France’s competition authority handed Novartis and Roche a hefty fine for allegedly using abusive practices to boost sales of their eye disease drug Lucentis, and the appeals court has overturned the judgment.
The Autorité de la Concurrence levied a €444 million ($475 million) penalty on the two drugmakers in 2020, saying they had illegally prevented the use of an older and cheaper medicine to treat patients with wet age-related macular degeneration (AMD).
The aim was to avoid cannibalising sales of Lucentis (ranibizumab), which pulled in nearly $4 billion in sales for the two partners in 2019 before the pandemic disrupted access to treatment the following year. Lucentis started to lose patent protection in 2021.
The French authorities said Novartis and Roche had abused a dominant position in the market to force use of Lucentis rather than Roche’s Avastin (bevacizumab), an older drug that had been shown in independent trials to treat AMD, but was not filed for approval in that indication.
Both drugs work by inhibiting VEGF, and in turn the abnormal growth of blood vessels that is seen in both cancer and AMD.
As Avastin was around 30-fold cheaper than Lucentis at the time, there was a drive to use the cancer drug off-label in AMD in a number of markets, particularly in cost-conscious Europe where some authorities approved reimbursement of the lower-priced drug.
Novartis and Roche launched legal actions to try to block off-label use of Avastin for AMD, but according to France’s competition authority also colluded in “obstructive behaviour” to restrict access and also spread “alarmist” and “misleading” statements about the risks associated with the cheaper drug.
Novartis was fined €385 million, with Roche and its Genentech unit on the hook for €59 million, amid allegations that Roche had refused for months to provide supplies of Avastin to France’s National Drug Safety Authority (ANSM) for a head-to-head study of the two drugs in AMD.
That decision has now been overturned, with the French appeals court concluding that they did not abuse their position, and had been “measured” in their comments about Avastin use in AMD.
It also concluded that Roche's refusal to supply Avastin for the clinical trial would not have had an anti-competitive effect.
Novartis and Roche have repeatedly asserted that there were no grounds for using Avastin off-label and supported that undermined the drug regulatory system.
Novartis names Firmenich CEO as Sandoz chair
In other news this morning, Novartis also confirmed the appointment of Gilbert Ghostine, chief executive of Swiss perfume business Firmenich since 2014, as chairman-designate of Sandoz once the generics business is spun out in the second half of 2023.
