Antitrust authorities in Italy have opened an investigation into claims Novartis and Roche colluded to restrict the availability of a lower-cost treatment for age-related macular degeneration, a leading cause of blindness.
The Italian competition authority (AGCM) acted after two private healthcare facilities complained that Roche was blocking use of its Avastin (bevacizumab) product for ophthalmic application such as AMD in order to boost sales of Novartis' more expensive Lucentis (ranibizumab).
The active ingredients in both medicines were developed by Roche subsidiary Genentech, with Novartis marketing Lucentis under license in Europe. On February 14, the AGCM carried out inspections at the premises of some Italian branches of Roche and Novartis.
Roche has always maintained that Lucentis and Avastin are very different drugs, with the side effect profile of Avastin in AMD not fully understood, and that off-label use of the latter in AMD is illegal in many countries around the world.
However, the Italian authority is looking into suggestions that Roche acted illegally by failing to seek approval of Avastin in AMD, despite "several studies" indicating that the drug is as effective as Lucentis in this indication, according to an AGCM statement.
There is reported to be widespread use of off-label Avastin for AMD by ophthalmologists in the US, China and other parts of the world following the publication of studies - such as the publicly-funded CATT and IVAN trials - which found the drug was as effective as Lucentis.
At the time the results were released, Novartis argued that the study was underpowered to explore safety issues and was not designed to show differences between the two drugs.
Novartis has made some concessions as the debate rumbles on. Last summer, the company cut the price of Lucentis in the UK in order to prevent off-label use of Avastin for AMD by a primary care trust.
The deadline for the AGCM inquiry has been set at December 20, 2013.