Italy’s antitrust authority has started a probe against Novartis, Roche’s Genentech, Biogen, and Samsung Bioepis over the alleged delayed launch of eye drug Byooviz, a biosimilar to Lucentis.
The Autorità Garante della Concorrenza e del Mercato (AGCM) claimed that the pharmaceutical companies and some of their Italian, Dutch, and UK arms coordinated their commercial strategies to delay the introduction of Byooviz in Italy.
According to AGCM, searches were conducted in Italy with the assistance of the finance police, and in the Netherlands by the Dutch regulator.
Developed and marketed by Samsung Bioepis, Byooviz is a drug formulated with ranibizumab. Lucentis was developed by Genentech and distributed in Italy and other countries outside the US by Novartis.
In September 2021, Samsung Bioepis and Biogen received approval from the US Food and Drug Administration (FDA) for Byooviz.
Ranibizumab injections are indicated in the management and treatment of neovascular age-related macular degeneration and macular oedema in the eye.
The AGCM stated that the suspected delay in the launch of Byooviz could have restricted patient access and affected prices. Additionally, it may have adverse implications on potential cost savings for the Italian national health services, the regulator noted.
As per a report in Reuters, a spokeswoman from Novartis said that the Swiss company is collaborating with AGCM by giving the requested information.
The spokeswoman has been quoted by the news agency, as saying : “Novartis strongly believes that it has acted appropriately and in accordance with competition law and in the best interests of patients.”
Roche conveyed in a separate email to Reuters that it abstains from providing commentary on regulatory or legal investigations, whether potential or ongoing.
The statement underscored that for both the company and Genentech, biosimilar competition is a routine aspect of a treatment’s life cycle. Additionally, the company informed the publication that biosimilars contribute to the financial stability of healthcare systems while also fostering innovation.
Moreover, the publication reported that Samsung Bioepis and Biogen are cooperating with the ongoing investigation and review.
