EU looks at eye drug allegations
pharmafile | May 8, 2014 | News story | Sales and Marketing | EU, Lucentis, Novartis, Roche, avastin, offlabel
European Union regulators are considering whether they need to take any action over the recent allegations of anti-competitiveness involving Roche and Novartis.
The companies have been accused of colluding to stop Roche’s cancer drug Avastin (bevacizumab) from being used to treat wet age-related macular degeneration (AMD).
Off-label prescribing of Avastin for this eye condition has been relatively common even though the drug – unlike the more expensive Lucentis (ranibuzimab), which is co-marketed by Novartis and Roche – is not approved for this licence.
But the brands are chemically similar, and by prescribing Avastin off-label health authorities have saved money.
There has been no formal move by the European Commission, but in remarks reported by Bloomberg, Joaquin Almunia, vice president of the EC in charge of competition issues, says regulators were ‘gathering information’.
The European Commission “will assess whether further action is needed in this area”, Almunia adds, although he would not say what the ‘precise content’ of the current investigation is.
In March, Reuters reported that Italy’s antitrust authority fined the two firms €182.5 million after alleging that they prevented doctors prescribing Avastin for wet AMD in favour of Lucentis.
Roche and Novartis have consistently denied that there is any such agreement between them.
Last month French competition authorities began their own investigation: a notice on the website of the Authorite de la Concurrence said that unannounced visits were made on 8 April to unnamed companies in France suspected of being involved in ‘anti-competitive activities’.
Documents have been removed from the offices but the Authorite declined to comment, telling Pharmafile that the procedure was ‘confidential’.
This prescription issue was the subject of a legal battle in the UK, where the Southampton, Hampshire, Isle of Wight and Portsmouth (SHIP) cluster was making Avastin available to patients.
The cluster decided to reverse its stance after Novartis offered Lucentis at a discounted price although the size of the price cut remains confidential.
Adam Hill
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