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France Fines Roche, Novartis 444 Mln Euros in Ongoing Eye Drug Clash France Fines Roche, Novartis 444 Mln Euros in Ongoing Eye Drug Clash

ZURICH (Reuters) – Switzerland’s Novartis and Roche were fined 444 million euros ($522 million) by France, after its competition authority said on Wednesday they used abusive practices to push costly eye injection Lucentis over a cheaper drug.

Novartis, which said it would appeal, is facing high stakes in protecting Lucentis sales in Europe, after its newest eye drug, Beovu, has run into safety concerns that have slowed uptake.

Novartis must pay 385 million euros and Roche about 60 million euros, according to the decision.

Roche and Novartis are partners on Lucentis, with Roche selling it the United States and Novartis selling it in Europe.

The fines are the latest development in a running battle between the drugmakers and countries where some doctors have turned to Roche’s cheaper Avastin to replace costly Lucentis, to treat patients with blindness-causing macular degeneration (AMD).

Lucentis was developed for AMD, but works like cancer drug Avastin by inhibiting blood vessel growth. Avastin is used “off-label” for AMD.

Roche and Novartis abused their dominant position to push Lucentis at Avastin’s expense, the French competition watchdog said, adding Novartis was also punished for “unjustifiably exaggerating” Avastin’s risks.

The French authority said Lucentis, injected roughly monthly, costs 1,161 euros per injection, while Avastin runs 30 to 30 euros per shot.

Similar disputes have emerged elsewhere, as countries seek to reduce costs.

In 2018, Novartis and Roche lost a bid in Britain to block doctors from making Avastin the preferred option for AMD (https://reut.rs/336rz1e).

A “disappointed” Roche said it would “assess our next steps”.

Novartis said a French rule allowing off-label use of medicines in diseases with approved treatments threatens the system of ensuring safe and effective drugs.

“This decision relies on a gross misinterpretation of the facts and a distortion of previous case law,” Novartis said.

($1 = 0.85 euros)