Novartis, Roche unit and others face Italy antitrust probe over eye drug

ROME (Reuters) -Italy's antitrust regulator said on Thursday it had launched an investigation into pharmaceutical companies including Novartis and Roche-controlled Genentech for having potentially restricted competition in the sale of an eye drug.

Biopharma developer Samsung Bioepis, biotechs Biogen and Genentech, and Novartis, and some of their Italian, Dutch and UK units, allegedly coordinated their commercial strategies to delay the launch in Italy of Byooviz, a drug made with ranibizumab and developed and sold by Samsung Bioepis, the watchdog said in a statement.

Searches had been carried out in Italy, with the support of the finance police, and in the Netherlands by the Dutch regulator, it added.

Byooviz is a biosimilar of Lucentis, which was developed by Genentech and sold in Italy and other countries outside the U.S. by Novartis.

A biosimilar has a structure that closely mimics an existing biologic drug but is not exactly alike.

Ranibizumab injections are used to manage and treat neovascular age-related macular degeneration and macular edema in the eye.

The suspected delay may have limited the availability and prices for patients but may also have negative repercussions on possible savings by the Italian national health services, the authority said.

Novartis is cooperating with the authority, providing the information requested, a company spokeswoman said in an emailed statement to Reuters.

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

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

It added that for the company and Genentech, biosimilar competition is a normal part of a treatment's life cycle and that biosimilars "have an important role to play in supporting the financial sustainability of healthcare systems, while making headroom for innovation".

Samsung Bioepis and Biogen are cooperating with the ongoing investigation and review, the companies' spokespeople 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)

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