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French regulatory authorities seek information from Roche on Avastin use in AMD

The French regulatory agency, Agence nationale de sécurité de médicament et des produits de santé (ANSM), has confirmed that it has written to Swiss pharmaceutical company Roche, requesting information on the use of Avastin (bevacizumab) to treat AMD. The correspondence, posted on the ANSM website, seeks to obtain any data that Roche holds on the safety and efficacy of Avastin for the treatment of AMD. The request comes on the back of a significant independent research by the Cochrane Collaboration, an independent network of health practitioners with a mission to, ”promote evidence-informed health decision-making by producing high-quality, relevant, accessible systematic reviews and other synthesised research evidence”. In summary, the Cochrane review of nine non-industry randomized controlled trials showed that injecting bevacizumab into the eye did not give rise to serious side effects and that there was no evidence to support current health policies favoring Lucentis (ranibizumab).


The French authorities had previously voted on a draft law to permit the use of off-label bevacizumab, rather than ranibizumab, for AMD treatment, a move which could save the French healthcare system up to €200 million per annum. On July 8th, 2014, a vote by the French National Assembly approved a draft law proposing to permit doctors’ discretion in the use off-label drugs, even in the context of an alternative approved drug being available. The draft law had referenced Roche’s anti-cancer drug (bevacizumab) as an off-label treatment for wet AMD. Economic circumstances across the EU, coupled with significant independent evidence-based analysis, has accelerated efforts by a number of government agencies to ensure optimal value for money is obtained by health services and patients alike.


The step-up by French authorities follows a more active engagement on healthcare costs and audits on-going in other EU jurisdictions. In March, Italian prosecutors opened a formal investigation against Roche and Novartis, understood to involve four company executives on suspicion of “fraud and manipulation of the pharmaceutical market”.   The investigation followed on a previous decision by the Italian Competition Authority to fine Novartis €92 million ($127.8 million) and Roche €90.5 million ($125.8 million) for alleged anti-competitive practices between the companies regarding the sale of ranibizumab and bevacizumab in Italy. The Competition Authority alleged that the global pharmaceutical companies presented bevacizumab as a riskier drug (compared to ranibizumab) in order to influence the prescribing activities of doctors towards the more expensive ranibizumab drug. Anti-VEGF treatments for ocular indications represent significant revenue streams for a small number of large pharmaceutical companies. Worldwide sales in 2014 for ranibizumab are expected to reach $4.2Bn while comparable numbers for Regeneron’s competing drug, Eylea (aflibercept), are estimated to reach $1.8BN in the same period.