close
close

Novartis, a unit of Roche and other companies face an Italian antitrust investigation into an eye drug

ROME (Reuters) – Italy’s antitrust authority said on Thursday it had opened an investigation into pharmaceutical companies, including those controlled by Novartis and Roche Genentech, over a potential restriction of competition in the sale of eye medicines.

Biopharma developer Samsung Bioepis, biotechs Biogen and Genentech and Novartis, as well as some of their entities in Italy, the Netherlands and the United Kingdom, allegedly coordinated their commercial strategies to delay the launch in Italy of Byooviz, a drug made from ranibizumab and developed and marketed by Samsung Bioepis, the supervisory authority said in a statement.

She added that the searches were carried out in Italy with the support of the financial police and in the Netherlands by the Dutch regulator.

Byooviz is a biosimilar to Lucentis, developed by Genentech and marketed in Italy and other countries outside the US by Novartis.

A biosimilar medicine has a structure that closely mimics an existing biologic medicine, but is not exactly similar.

Ranibizumab injections are used to treat neovascular macular degeneration and macular edema in the eye.

The suspected delay may have reduced availability and prices for patients, but could also have negative consequences for possible savings for Italy’s national health service, the body said.

Novartis is cooperating with authorities by providing requested information, a company spokeswoman said in a statement emailed to Reuters.

“Novartis firmly believes that it has acted appropriately, in accordance with competition law and in the best interests of patients,” she added.

In a separate email, Roche said it does not comment on regulatory or legal investigations, potential or ongoing.

She added that for the company and Genentech, biosimilar competition is a normal part of the drug lifecycle and that biosimilars “have an important role to play in supporting the financial sustainability of healthcare systems while providing space for innovation.”

Samsung Bioepis and Biogen are cooperating in the ongoing investigation and review, spokespeople for the companies said in two separate emailed comments.

(Reporting by Giulia Segreti in Rome and Paul Arnold in Zurich, Editing by Alvise Armellini, Lincoln Feast and Sriraj Kalluvila)