Italian probe into coordinated delay of Lucentis biosimilar targets Biogen, Novartis
06 Jun 2024
Drug ApprovalLicense out/inBiosimilar
Italy’s antitrust watchdog launched a probe into a number of companies over allegations that they acted together to delay the launch of a biosimilar version of Roche’s Lucentis (ranibizumab) in the country. The Italian Competition Authority, known as AGCM, said on Thursday that Roche, along with Novartis, which markets the anti-VEGF therapy in Italy, as well as Biogen and Samsung Bioepis, are under investigation.
Biogen and Samsung Bioepis’ biosimilar version of Lucentis, sold as Byooviz, gained approval in the EU in 2021. Both the originator product and the biosimilar version are approved to treat age-related macular degeneration (AMD), macular oedema caused by diabetes and diabetic retinopathy.
AGCM alleges the four companies coordinated their commercial strategies in order to delay the launch of Byooviz in Italy, with the anticompetitive agreement not only limiting availability and prices for patients, but also potential savings by the Italian national health services.
Delay in exchange for early US launch
The competition authority claims that in exchange for being able to launch Byooviz early in the US, Biogen and Samsung Bioepis agreed to postpone its entry into other markets, including Italy, where patents on Lucentis expired in July 2022.
According to the AGCM, at the end of May inspections were carried out at offices of Biogen and Novartis in Italy, while Dutch competition authorities conducted inspections at the premises of Samsung Bioepis in the Netherlands.
Samsung Bioepis and Novartis said they would fully cooperate with the investigation, with a spokesperson for the Swiss drugmaker adding that the company acted in accordance with competition law and in the best interests of its patients.
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