Italy launches antitrust case against Novartis, Roche for biosim delay collusion

In a significant development, the Italian Competition Authority (AGCM) has initiated an antitrust investigation targeting several pharmaceutical giants, including Novartis, Genentech, Biogen, and Samsung Bioepis. The investigation centers on allegations that these companies colluded to hinder the market entry of Byooviz, a biosimilar of the blockbuster eye drug Lucentis, in Italy.

Byooviz holds the distinction of being the first biosimilar of Lucentis, a medication developed to treat various eye conditions such as wet age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. The original drug, Lucentis, is marketed by Genentech in the U.S. and by Novartis in other regions. Byooviz is produced by Samsung Bioepis and marketed by Biogen. It received approval in both Europe and the U.S. in 2021 and was the first ophthalmology biosimilar to enter the market.

The AGCM has accused the companies and their respective business units in Italy, the Netherlands, and the U.K. of coordinating their commercial strategies to delay the launch of Byooviz. According to Reuters, this alleged delay could have restricted patient access to the treatment and impacted healthcare expenditures, citing an official statement from the AGCM. As part of the investigation, searches have already been conducted in the offices of the implicated companies in Italy and the Netherlands.

Representatives from Novartis have confirmed the company's cooperation with the AGCM's investigation. "Novartis strongly believes that it has acted appropriately and in compliance with competition law, always prioritizing the best interests of patients," a company representative stated. Novartis emphasized its commitment to patient health, ethical standards, and regulatory compliance.

Samsung Bioepis and Biogen have also expressed their willingness to cooperate fully with the investigation, according to statements provided via email. However, Roche and Genentech have chosen not to comment on the ongoing regulatory or legal matters. Despite this, a spokesperson for the companies acknowledged that biosimilar competition is a standard aspect of the lifecycle of biologic treatments. The spokesperson stressed the importance of biosimilars in promoting the financial sustainability of healthcare systems and creating room for innovation.

"Our primary objective remains the discovery and development of new medicines and treatments that enhance the health and quality of life for individuals living with specific conditions, especially in areas with significant unmet medical needs," the spokesperson added.

The investigation by the AGCM underscores the heightened scrutiny pharmaceutical companies face regarding their competitive practices, especially in the rapidly growing field of biosimilars. As the probe continues, it will be crucial to monitor how these allegations and the subsequent findings impact the companies involved and the broader pharmaceutical industry. The outcome could potentially reshape competitive dynamics and influence future regulatory policies concerning biosimilars and their market entry strategies.