Italy opens antitrust case against Novartis, Roche and others, claiming collusion to delay biosim launch

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来源: FiercePharma

Byooviz was the first biosimilar to Roche and Novartis' blockbuster eye drug Lucentis.

A new antitrust investigation in Italy has ensnared Novartis, Genentech, Biogen and Samsung Bioepis for allegedly colluding to suppress competition of a Lucentis biosimilar in the country.

Italy’s antitrust agency, called the Italian Competition Authority or AGCM, accused the companies and some of their Italian, Dutch and U.K. business units of coordinating their commercial strategies to stall the launch of Samsung Bioepis and Biogen's Byooviz, Reuters first reported.

The delay could have not only limited availability and access for patients, but could have affected healthcare spending, Reuters reported from an AGCM statement.

Office searches have already been initiated in Italy and the Netherlands, the AGCM said.

Roche’s Genentech and Novartis each have their hands on the blockbuster injectable eye drug Lucentis, with Genentech marketing it in the U.S. and Novartis responsible for its commercialization in other markets. Byooviz is manufactured by Samsung Bioepis and commercialized by Biogen. Biogen originally formed Samsung Bioepis with Samsung Biologics in 2021 and sold its equity stake in 2022, shortly before Byooviz launched in the U.S.

Byooviz was approved in Europe and the U.S. in 2021 and was the first ophthalmology biosimilar and the first copy of Lucentis, which treats several eye conditions including wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization.

A Novartis representative confirmed that the company is cooperating with the Italian Competition Authority and has provided the requested information.

“Novartis strongly believes that it has acted appropriately and in accordance with competition law and in the best interests of patients,” the representative said. “Novartis is committed to improving patient health, adhering to high ethical standards and in compliance with laws and regulations.

Samsung Bioepis is “fully cooperating” with the probe, as is Biogen, the companies said over email.

Roche and Genentech do not comment on regulatory or legal investigations, a spokesperson said, but see biosimilar competition as “a normal part of a biologic treatment’s life cycle." The company further said it believes biosimilars “have an important role to play in supporting the financial sustainability of healthcare systems while making headroom for innovation.”

“Our focus remains the discovery and development of novel medicines and treatments that improve the health and quality of life of people living with certain conditions, in areas where there is an unmet medical need,” the spokesperson added.

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