Italian Antitrust Authorities Investigate Novartis, Roche, and Others for Collusion in Biosimilar Launch Delay
Italy’s antitrust agency, the Italian Competition Authority (AGCM), has initiated an investigation into Novartis, Genentech, Biogen, and Samsung Bioepis for allegedly conspiring to delay the launch of a biosimilar to the blockbuster eye drug Lucentis. This biosimilar, known as Byooviz, is the first of its kind and aims to provide a more affordable alternative to Lucentis, which is used to treat various eye conditions.
Details of the Investigation
The AGCM
claims that the companies, along with some of their business units in Italy, the Netherlands, and the U.K., coordinated their commercial strategies to stall the introduction of Byooviz, developed by Samsung Bioepis and commercialized by Biogen. The alleged collusion could have restricted patient access to the biosimilar and impacted healthcare spending.
Background on Lucentis and Byooviz
Lucentis, marketed by Genentech in the U.S. and by Novartis in other markets, is an injectable eye drug used to treat conditions like wet age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. Byooviz, the biosimilar to Lucentis, was approved in Europe and the U.S. in 2021 and is the first ophthalmology biosimilar of its kind.
Company Responses
A representative from Novartis confirmed that the company is cooperating with the AGCM and has provided the requested information. The representative asserted that Novartis believes it acted appropriately and in compliance with competition laws and in the best interests of patients. Novartis emphasized its commitment to improving patient health and adhering to high ethical standards.
Samsung Bioepis and Biogen also stated they are fully cooperating with the investigation. Roche and Genentech declined to comment on regulatory or legal investigations but acknowledged that biosimilar competition is a normal part of the lifecycle of biologic treatments. They also highlighted the importance of biosimilars in supporting the financial sustainability of healthcare systems and fostering innovation.
Implications of the Investigation
The AGCM’s investigation into the alleged collusion has involved searches of offices in Italy and the Netherlands. If the accusations are confirmed, it could lead to significant repercussions for the companies involved, potentially including fines and changes to their commercial practices.
Broader Context
This case highlights ongoing scrutiny in the pharmaceutical industry regarding competitive practices, especially concerning biosimilars. Biosimilars are critical for reducing healthcare costs and increasing access to treatments. Delaying their market entry can have substantial financial and health implications.
Conclusion
The Italian antitrust case against Novartis, Roche, and other companies underscores the importance of fair competition in the pharmaceutical industry. As the investigation unfolds, it will be crucial to monitor its impact on the availability of biosimilars and the broader implications for industry practices and patient access to affordable medications.
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Source: Fierce Pharma