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红迪博士实验室在Obeda供应中断之际推出新仿制Ozempic品牌Dr Reddy's rolls out new generic Ozempic brands amid Obeda supply disruption

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2023年10月3日,在丹麦海勒鲁普,马兹·克罗格斯高·汤姆森的办公室里摆放着分子司美格鲁肽的科学模型。司美格鲁肽是诺和诺德重磅畅销糖尿病药物Ozempic和减肥药物Wegovy的活性成分。路透社/阿里·威瑟斯/资料图片Scientific model of the molecule semaglutide which is the active ingredient in Novo Nordisk's mega-blockbuster diabetes drug Ozempic and weight-loss drug Wegovy sits in the office of Mads Krogsgaard Thomsen in Hellerup, Denmark, October 3, 2023. REUTERS/Ali Withers/File Photo

红迪实验室已扩大其司美格鲁肽(Ozempic)仿制药组合,推出两个新品牌,据路透社审阅的产品照片和营销材料显示,此举是在供应中断冲击其原版“Obeda”注射剂在印度快速增长的司美格鲁肽市场销售后采取的。

Reddy's Laboratories (REDY.NS) has expanded its portfolio of generic versions of Ozempic with two new brands, according to product photographs and marketing materials reviewed by Reuters, after supply disruptions hit sales of its original Obeda injection in India's fast-growing semaglutide market.

“Obeda Pro”和“Obeda Plus”由不同于原版“Obeda”注射剂的制造商生产,后者供应于7月被叫停,此前红迪实验室在活性成分中发现了一种杂质。

Obeda Pro and Obeda Plus are made by a different manufacturer than the original Obeda injectable, supplies of which were halted in July after Dr Reddy's discovered an impurity in the active ingredient.

多位分销商告诉路透社,红迪实验室很可能停止供应“Obeda”,转而专注于“Obeda Pro”和“Obeda Plus”。

Dr Reddy's is likely to discontinue supplies of Obeda and instead focus on Obeda Pro and Obeda Plus, several distributors told Reuters.

一位药品分销商在不愿具名的情况下表示,因为未获授权接受媒体采访,“公司称‘Obeda’注射剂存在一些技术问题,并从我们这里召回了库存。他们说将改为供应‘Obeda Pro’。”

"The company said there were some technical issues with Obeda injectable, and they recalled stocks from us. They said they would instead supply Obeda Pro," a drug distributor said on condition of anonymity as they were not authorized to speak to the media.

针对路透社的置评请求,红迪实验室表示,“Obeda Pro”和“Obeda Plus”等产品的开发和上市规划在7月供应中断问题发生前早已在进行中。

The development and launch planning for products such as Obeda Pro and Obeda Plus were under way well before the July supply disruption issues, Dr Reddy's said in response to a Reuters request for comment.

该公司称:“多个司美格鲁肽品牌和制造安排的存在反映了我们投资组合策略的广度,不应被解读为推出一种产品是为了替代另一种产品的证据。”

"The presence of multiple semaglutide brands and manufacturing arrangements reflects the breadth of our portfolio strategy and should not be interpreted as evidence that one product was launched to replace another," it said.

据路透社审阅的一份通知,红迪实验室于7月因“技术评估”召回了“Obeda”注射剂。公司未回复路透社关于召回是否与杂质有关的提问。该药物的口服版本未被召回。

Dr Reddy's recalled Obeda injection in July "for technical evaluation," according to a notice reviewed by Reuters. The company did not reply to a Reuters question on whether the recall was related to the impurity. An oral version of the drug was not recalled.

在司美格鲁肽在印度失去专利保护后,红迪实验室于3月在印度推出了“Obeda”——诺和诺德糖尿病药物的仿制版本,引发国内制药公司竞相推出该药物低价版本的竞争。

Dr Reddy's launched Obeda — a generic version of Novo Nordisk's (NOVOb.CO) diabetes drug — in India in March after semaglutide lost patent protection in the country, setting off a race among domestic pharma companies to launch lower-cost versions of the drug.

司美格鲁肽能抑制食欲,也是诺和诺德畅销减肥药“Wegovy”的活性成分。

Semaglutide, which suppresses appetite, is also the active ingredient in Novo's blockbuster weight-loss drug Wegovy.

Obeda Plus 和 Obeda Pro 有不同的剂量强度,就像 Ozempic 和 Wegovy 一样。

Obeda Plus and Obeda Pro are available in different dose strengths, just like Ozempic and Wegovy.

研究机构 Pharmarack 3 月估计,印度司美格鲁类药物的国内市场将在 2030 年增长至 800 亿卢比(约 8.4399 亿美元)。

Research firm Pharmarack estimated in March that the domestic market for semaglutide drugs will grow to 80 billion rupees ($843.99 million) by 2030.

Dr Reddy's 7 月表示,Obeda 注射剂的供应将不可用,直到 11 月。分析师当时警告称,如果供应不能迅速恢复,该公司在印度日益激烈的司美格鲁类药物市场竞争中,面临失去市场份额的风险。Dr Reddy's 未回复关于其是否已解决杂质问题的提问。

Dr Reddy's said in July that supplies of Obeda injections would be unavailable until November. Analysts warned at the time that the company risked losing market share in India's increasingly competitive semaglutide market if supplies were not restored quickly. Dr Reddy's did not reply to a question on whether it had resolved the impurity issue.

路透社审阅的包装材料显示,Obeda 由受托制造商 OneSource Specialty Pharma(ONEO.NS)生产。根据路透社审阅的供货发票,Obeda Pro 和 Obeda Plus 于 7 月下旬开始出现在市场上,由 Hetero Labs 生产。

Packaging materials reviewed by Reuters showed Obeda was manufactured by contract manufacturer OneSource Specialty Pharma (ONEO.NS). Obeda Pro and Obeda Plus, which began appearing in the market in late July according to supply invoices reviewed by Reuters, are manufactured by Hetero Labs.

Hetero Labs 和 OneSource Specialty Pharma 均未回复置评请求。

Hetero Labs and OneSource Specialty Pharma did not respond to requests for comment.

根据研究机构 Pharmarack 的数据,截至 9 月,Dr Reddy's 在印度销售了约 44.2 万单位的仿制司美格鲁类药物。相比之下,印度最大药企 Sun Pharma(SUN.NS)销售了 15.1 万单位司美格鲁类药物。

Dr Reddy's sold about 442,000 units of generic semaglutide through September in India, according to research firm Pharmarack. By comparison, India's largest drugmaker Sun Pharma (SUN.NS) sold 151,000 semaglutide units.

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