Italian Investigation into Lucentis Biosimilar Delay Targets Biogen, Novartis

Italy’s antitrust authority, known as the Italian Competition Authority (AGCM), has initiated an investigation into several pharmaceutical companies over accusations that they colluded to delay the launch of a biosimilar version of Roche’s Lucentis (ranibizumab) in Italy. On Thursday, AGCM announced that Roche, Novartis (the marketer of Lucentis in Italy), Biogen, and Samsung Bioepis are under scrutiny for potentially violating competition laws.

The case centers around Byooviz, a biosimilar version of Lucentis developed by Biogen and Samsung Bioepis, which received approval in the European Union in 2021. Both the original Lucentis and its biosimilar are designed to treat conditions such as age-related macular degeneration (AMD), macular edema caused by diabetes, and diabetic retinopathy.

AGCM alleges that the four companies conspired to delay the introduction of Byooviz into the Italian market. This purported anticompetitive agreement not only restricted the availability and pricing options for patients but also hindered potential cost savings for the Italian national health services. The watchdog suggests that the delay was part of a strategy where Biogen and Samsung Bioepis agreed to defer the release of Byooviz in certain markets, including Italy, in exchange for an earlier launch in the United States. The patents for Lucentis in Italy expired in July 2022, yet Byooviz has not been introduced to the market as expected.

To investigate these claims, AGCM conducted inspections at the offices of Biogen and Novartis in Italy at the end of May. Simultaneously, Dutch competition authorities inspected the premises of Samsung Bioepis in the Netherlands. These inspections aim to uncover evidence of the alleged agreement and its impact on the Italian market.

In response to the investigation, Samsung Bioepis and Novartis have expressed their willingness to fully cooperate with AGCM. A spokesperson for Novartis emphasized that the company has adhered to competition laws and acted in the best interests of its patients. This stance indicates that, despite the allegations, the companies involved assert their compliance with legal frameworks and commitment to patient care.

The case highlights the complex dynamics within the pharmaceutical industry, especially regarding the introduction of biosimilars, which are often seen as cost-effective alternatives to original biologic drugs. By delaying the availability of these alternatives, the alleged agreement could have significant implications for healthcare costs and patient access to treatment in Italy.

The outcome of AGCM’s investigation could lead to further scrutiny of pharmaceutical practices in Europe and potentially result in penalties if the companies are found guilty of anticompetitive behavior. This case underscores the importance of maintaining fair competition within the industry to ensure that patients have access to affordable and effective treatments.

As the investigation progresses, it will be crucial to monitor any developments and the responses from the involved companies. This case could set a precedent for how similar allegations are handled in the future, potentially influencing regulatory approaches and competitive practices within the pharmaceutical sector globally.