Italian antitrust authorities are investigating four companies over alleged collusion to delay the introduction of a new biosimilar to Roche’s blockbuster eye drug Lucentis.
The Italian Competition Authority said Thursday that it was investigating whether Novartis, Biogen, Samsung Bioepis and Roche’s Genentech worked together to delay the launch of Byooviz in Italy, according to an English translation of the statement.
Samsung Bioepis and Biogen’s monoclonal antibody Byooviz, also known as ranibizumab, is biosimilar to Lucentis and used to treat conditions like age-related macular degeneration and forms of macular edema. The brand-name version is marketed in Italy by Novartis.
A spokesperson for Novartis confirmed the investigation and said the company was “cooperating with the authority and [has] provided the requested information.”
“Novartis strongly believes that it has acted appropriately and in accordance with competition law and in the best interests of patients,” the spokesperson added.
Spokespeople for Samsung Bioepis and Biogen both said their respective companies were cooperating with the probe.
Genentech did not respond by the time of publication.
Italy’s antitrust watchdog said in its announcement that it inspected Novartis and Biogen offices on May 28 in conjunction with the country’s finance police. Antitrust authorities in the Netherlands carried out similar inspections at Samsung Bioepis’ offices in Delft.
This is not the first time that Lucentis has been at the center of a European antitrust case. A fine was levied against Roche and Novartis by French authorities back in 2020 after claims the two worked together to hoard market share and exclude Genentech’s Avastin. Despite Avastin being a cancer drug that was not approved to treat wet age-related macular degeneration (AMD), researchers found it had similar efficacy to Lucentis.
An appeals court sided with the Lucentis makers in 2023, overturning the $411.9 million and $63.9 million fines levied against Novartis and Roche, respectively. The court concluded that communications between the companies couldn’t be considered anti-competitive.