Italian Antitrust Agency Investigates Novartis, Biogen, and Others Over Lucentis Biosimilar

1. Investigation Launched: Italy's antitrust regulator, the Italian Competition Authority (AGCM), has launched an investigation into pharmaceutical companies including Novartis, Biogen, Samsung Bioepis, and Genentech over alleged collusion to delay the introduction of a new biosimilar for the eye drug Lucentis.
2. Alleged Collusion: The companies are accused of coordinating their commercial strategies to stall the launch of Byooviz, a biosimilar developed by Samsung Bioepis and commercialized by Biogen, which could have limited availability and prices for patients and affected healthcare spending.
3. Searches Conducted: Office searches have been carried out in Italy and the Netherlands, with the support of the finance police and the Dutch regulator, to gather evidence for the investigation.
4. Companies Involved: The investigation involves Novartis, Biogen, Samsung Bioepis, and Genentech, as well as some of their Italian, Dutch, and UK units.
5. Byooviz Background: Byooviz is a biosimilar of Lucentis, which was developed by Genentech and sold in Italy and other countries outside the U.S. by Novartis. It is used to manage and treat neovascular age-related macular degeneration and macular edema in the eye.
6. Company Responses: Novartis, Samsung Bioepis, and Biogen are cooperating with the investigation, while Roche and Genentech have declined to comment on the ongoing probe.