Drug maker

药品制造商

Lupin

鲁宾

on Monday said it has received approval from the US health regulator for a biosimilar indicated for the treatment of neutropenia in cancer patients.

周一表示，已获得美国健康监管机构批准，用于治疗癌症患者的中性粒细胞减少症的生物类似药。

The US Food and Drug Administration (USFDA) has approved

美国食品和药物管理局 (USFDA) 已批准

Armlupeg

手臂吊带

(pegfilgrastim-unne) 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe, as biosimilar to Neulasta (pegfilgrastim) injection, the Mumbai-based firm said in a statement.

该孟买公司表示，(培非格司亭-unne) 6毫克/0.6毫升单剂量预填充注射器用于皮下注射，是与Neulasta（培非格司亭）注射液相似的生物仿制药。

The product will be manufactured at the company's biotech facility in Pune, which was inspected by the USFDA prior to approval, it added.

该公司补充说，该产品将在浦那的生物技术工厂生产，该工厂在获批前已经过美国食品药品监督管理局的检查。

Armlupeg is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

Armlupeg 适用于在接受骨髓抑制性抗癌药物治疗的非髓系恶性肿瘤患者中，降低由发热性中性粒细胞减少症表现的感染发生率。

'This step marks a pivotal step in Lupin's ongoing commitment to providing more affordable, accessible medicines to the US patients. We look forward to introducing a robust portfolio of biosimilars over the next few years, which will help improve the quality of care for the communities and patients we serve,' said Vinita Gupta, CEO, Lupin..

“这一步标志着Lupin在持续致力于为美国患者提供更实惠、更可及的药物方面迈出了关键一步。我们期待在未来几年内推出一系列强大的生物类似药，这将有助于提高我们服务的社区和患者的护理质量，”Lupin首席执行官Vinita Gupta表示。

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As per IQVIA MAT data, Pegfilgrastim 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe had estimated annual sales of USD 1,295 million in the US for the 12 months ending September 2025.

根据IQVIA MAT数据，Pegfilgrastim 6 mg/0.6 mL单剂量预充注射器用于皮下注射，在截至2025年9月的12个月内，其在美国的年销售额估计为12.95亿美元。

Lupin shares were trading 0.47 per cent down at Rs 2,071.20 apiece on BSE.

Lupin的股票在BSE上每股交易价格为2,071.20卢比，下跌了0.47％。

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