A €444m anti-competitiveness fine given to Novartis and Roche has been revoked by the Paris Court of Appeal, which ruled that the two companies did not abuse their market power to boost sales of their shared eye disease drug Lucentis (ranibizumab).
The Autorité de la Concurrence first levied the fine on the companies in 2020, with the French competition authority charging the pair with illegally preventing the off-label use of an older and cheaper alternative drug to treat wet age-related macular degeneration (AMD).
Wet AMD develops when abnormal blood vessels grow into the macula and leak blood or fluid, leading to scarring and rapid loss of central vision. The condition can develop very suddenly and usually first affects people in their 50s and 60s.
Early detection and treatment of wet AMD may help reduce vision loss and, in some instances, early treatment may recover vision.
Treatment usually consists of regular eye injections, such as with Lucentis, to stop the growth of the abnormal blood vessels. Following diagnosis, patients will usually have a loading dose of three injections, once a month for three months, before being assessed to see if more injections are required.
Despite not being approved for wet AMD, Roche’s Avastin (bevacizumab) had been shown in independent trials to be effective in treating the condition and, as the cancer drug is significantly cheaper that Lucentis, there was a push for its off-label use in this indication.
In response, Novartis and Roche launched legal action to block the off-label use of Avastin and, according to the competition authority, worked to restrict access and spread misleading statements about the risks associated with the drug.
The fine has now been overturned, which was originally €385.1m against Novartis and €59.7m against Roche and its subsidiary Genentech, with the appeals court concluding that the companies had been ‘measured in tone’ in their comments about Avastin’s use in AMD.
The court also ruled that Roche’s refusal to supply samples of Avastin for a comparator clinical trial could not have had an anti-competitive effect.
Novartis and Roche have since confirmed the decision, with Novartis reasserting its opposition to the use of off-label products in an unlicensed indication.