March 05, 2014
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Italian agency fines Novartis, Roche 180 million euros for manipulation of pharmaceutical market

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Italian antitrust authority today fined Novartis and Roche Holdings 180 million euros for collusion and manipulation of the pharmaceutical market in Italy to prevent the use of Avastin in favor of the more expensive drug Lucentis.

The investigation was opened two years ago at the insistence of the Italian Society of Ophthalmology (SOI), following the decision of the Italian Medicines Regulatory Agency (AIFA) to block distribution of Avastin for the treatment of macular degeneration.

“AIFA backed up the declarations of Novartis and Roche that Avastin should not be used due to the higher risk profile in comparison with Lucentis. This after large trials like the CATT had proven substantial equivalence in efficacy and safety of the two drugs,” Matteo Piovella, MD, SOI President, told Ocular Surgery News.

The decision of AIFA sparked controversy in Italy, where Avastin was used in 90% of the cases requiring intravitreal anti-VEGF injections. By providing a tenfold cheaper option than the approved drug Lucentis, Avastin allowed the national healthcare system to provide a large number of patients with an affordable treatment, compatible with realistic hospital budgets.

This action by the antitrust is intended to “put things back in the right place, ” Piovella said. “The SOI will now renew the request to AIFA to re-establish the full legitimacy of the use of Avastin [in Italy]. We owe this to the 100,000 patients that have been refused treatment since hospitals could not afford the cost of Lucentis.”

Novartis denied allegations about anti-competitive practices between Novartis and Roche in Italy and will use its legal rights of defense to appeal.

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