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.

意大利一项新的反垄断调查已将诺华（Novartis）、基因泰克（Genentech）、比奥根（Biogen）和三星（Samsung）生物仿制药（Bioepis）抓获，涉嫌串通压制朗讯（Lucentis）生物仿制药在该国的竞争。

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.

据路透社首次报道，意大利反垄断机构意大利竞争管理局（AGCM）指责这两家公司及其意大利、荷兰和英国的部分业务部门协调其商业战略，以阻止三星Bioepis和Biogen的Byooviz的推出。

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

路透社（Reuters）在AGCM的一份声明中报道称，这一延误不仅限制了患者的可用性和访问权限，还可能影响医疗保健支出。

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

AGCM表示，意大利和荷兰已经开始进行办公室搜索。

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..

罗氏（Roche）的基因泰克（Genentech）和诺华（Novartis）分别拥有畅销的可注射眼药Lucentis，基因泰克（Genentech）在美国销售，诺华（Novartis）负责其在其他市场的商业化。Byooviz由三星Bioepis制造，并由Biogen商业化。Biogen最初于2021年与三星生物制品公司（Samsung Biologics）成立了三星生物科技公司（Samsung Bioepis），并于2022年出售了其股权，就在Byooviz在美国上市之前不久。。

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Biogen, Samsung Bioepis launch first US biosimilar, a copycat of Roche's Lucentis, at 40% discount

三星Bioepis推出首款仿制罗氏Lucentis的美国生物仿制药，折扣40%

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.

Byooviz于2021年在欧洲和美国获得批准，是第一个眼科生物仿制药和Lucentis的第一个副本，它治疗多种眼部疾病，包括湿性年龄相关性黄斑变性，视网膜静脉阻塞后的黄斑水肿和近视脉络膜新血管形成。

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

诺华的一位代表证实，该公司正在与意大利竞争管理局合作，并已提供所需信息。

“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.

这位代表说：“诺华坚信，它的行为是适当的，符合竞争法，符合患者的最佳利益。”。“诺华致力于改善患者健康，坚持高道德标准并遵守法律法规。

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

三星Bioepis和Biogen在电子邮件中表示，正在与调查“全面合作”。

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.”.

一位发言人表示，罗氏和基因泰克没有对监管或法律调查发表评论，但将生物仿制药竞争视为“生物治疗生命周期的正常组成部分”。该公司进一步表示，它认为生物仿制药“在支持医疗保健系统的财务可持续性同时为创新创造空间方面发挥着重要作用。”。

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Coherus, after FDA approval for interchangeable Lucentis biosim, plots October launch

Coherus在FDA批准可互换Lucentis biosim后，计划于10月推出

“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.

这位发言人补充说：“我们的重点仍然是在医疗需求未得到满足的地区发现和开发新的药物和治疗方法，以改善患有某些疾病的人的健康和生活质量。”。