
French court overturns €444M antitrust fine against Roche, Novartis
An anti-competitiveness fine has just been revoked against neighboring Swiss pharma giants Roche and Novartis.
A ruling from the Paris Court of Appeal Thursday cleared Roche and Novartis of a fine in the hundreds of millions of dollars, which was originally brought against the two several years ago amid accusations that the companies worked to disparage unapproved use of a cheaper drug in lieu of a more expensive drug.
The fine was first levied against the pharma neighbors — only located about 1.7 miles apart in Basel — back in 2020. France’s anti-competitiveness watchdog had charged the pair of conspiring to increase sales of Lucentis, a drug for wet age-related macular degeneration (AMD) that Roche makes and Novartis markets in Europe.
The suit at the time said that the companies had conspired to keep and increase the market share of the therapy to butt out Avastin, a drug made by Genentech and indicated for recurrent glioblastoma in adults. However, despite being around 2-4% of Lucentis’ price, Avastin was reported to have similar efficacy in wet AMD.
Avastin is not approved for wet AMD. Yet, a 2012 NIH study concluded that Avastin and Lucentis are “equivalent in treating age-related macular degeneration.”
Fast forward to 2023, and the Paris Court of Appeal overturned the fine, which was originally €385.1 million ($411.9 million) against Novartis and €59.7 million ($63.9 million) against Roche and its subsidiary Genentech.
The 121-page ruling from this week said that communications from the companies cannot be considered “alarmist or even misleading,” and that certain actions done on Roche’s part could not have had any anti-competitive effect.
A Roche spokesperson tells Endpoints News that Roche “welcomes the decision of the Paris Court of Appeal to revoke in all respects the decision of the FCA,” which added that the FCA had “condemned Roche and Novartis for abuse of a collective dominant position on the AMD treatment French market.”
Novartis said in a statement to Endpoints that the pharma giant “strongly contested these allegations from the outset and firmly believes the company has acted appropriately and in compliance with competition law and the interests of patients at all times.”
The pharma added that “Novartis firmly believes that measures encouraging widespread off-label use and reimbursement of a medicine in an unlicensed indication, despite the presence of licensed medicines on the market, are a threat to the established legal, medical and regulatory system that is in place to guarantee the approval and use of effective and safe medicines in patients.”