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Novartis, Roche unit and others face Italy antitrust probe over eye drug
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Novartis, Roche unit and others face Italy antitrust probe over eye drug
Jun 6, 2024 3:52 AM

ROME, June 6 (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 is fully cooperating with the ongoing

investigation, a spokesperson said in an emailed comment.

Biogen did not immediately respond to requests for comment.

(Reporting by Giulia Segreti in Rome and Paul Arnold in Zurich,

editing by Alvise Armellini, Lincoln Feast and Sriraj Kalluvila)

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