生物康公司周三宣布，已与罗氏旗下基因泰克公司就后者提起的美国专利诉讼达成和解。该诉讼涉及生物康拟开发的基因泰克畅销乳腺癌药物帕捷特的生物仿制药。
根据声明，此次和解使生物康能够争取到帕捷特生物仿制药的最早上市许可。据此，生物康计划于2027年第一季度在英国及欧盟市场推出其仿制药佩布里佐，并于2028年第三季度在美国上市。协议的其他条款则予以保密。
Roche's Genentech has settled a US lawsuit against Indian biopharmaceutical company Biocon over its proposed biosimilar of Genentech's blockbuster breast-cancer drug Perjeta, Biocon said Wednesday.
生物仿制药属于与传统化学药仿制药性质相近的生物制剂。由于生物制剂由活体细胞合成，其生产工艺极为复杂，无法像传统化学药那样进行完全复制。据罗氏财报显示，帕捷特去年是这家瑞士药企全球销量排名第六的药物，全年创收近29.7亿瑞士法郎（约合36.7亿美元）。
By Blake Brittain Biocon said in a statement that the settlement gives it the "earliest licensed launch dates" for a Perjeta biosimilar, allowing the company to launch its Pebrilzo in the first quarter of 2027 in the UK and European Union, and the third quarter of 2028 in the United States The release said that other terms of the agreement are confidential Biosimilars are versions of biologic drugs that are comparable to generics of traditional pharmaceuticals.
今年初，基因泰克曾以专利侵权为由在新泽西州对生物康提起诉讼，指控其仿制药开发行为违反相关专利规定。周三，应基因泰克申请，法院正式撤销了该诉讼。生物康方面未对诉讼指控作出公开回应。本案案号为：基因泰克公司诉生物康生物制药公司，新泽西州联邦地区法院，案号2:26-cv-09585。
Unlike traditional drugs, complex biologic drugs are made from living cells and cannot be copied exactly Genentech's biologic Perjeta was Switzerland-based Roche's sixth-best-selling drug last year, earning it nearly CHF 2.97 billion ($3.67 billion) in revenue worldwide, according to a company report Genentech sued Biocon in New Jersey earlier this year, alleging Biocon's biosimilar would infringe its patents The court dismissed the lawsuit on Wednesday at Genentech's request Biocon did not respond to Genentech's allegations in court The case is Genentech Inc v. Biocon Biologics Inc, US District Court for the District of New Jersey, No. 2:26-cv-09585