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| 1 | Phase 1 studies comparing safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01(a rituximab biosimilar) to reference rituximab in Chinese patients with CD20-positive B-cell lymphoma显示文摘Objective: This study aimed to compare the pharmacokinetic, pharmacodynamic and safety profiles of HLX01(a rituximab biosimilar) and reference rituximab sourced from China(Mab Thera?;rituximab-CN).Methods: Here we report the results of two phase 1 studies. In the phase 1 a, open-label, dose-escalation study(NCT03218072, CTR20140400), eligible patients received 250, 375 and 500 mg/m^(2) HLX01 sequentially at 7-day intervals, after confirming no dose-limiting toxicity(DLT). In the phase 1 b, double-blind study(NCT02584920,CTR20140764), eligible patients were given a single dose of 375 mg/m^(2) HLX01 or rituximab-CN. The primary endpoints included safety and tolerability parameters for the phase 1 a and the area under the plasma concentrationtime curve from time zero to day 91(AUC0-91 d) for the phase 1 b study. Equivalence was concluded if 90%confidence interval(90% CI) for the geometric least squares mean ratio(GLSMR) fell in the pre-specified equivalence criteria(80%-125%).Results: Between June 20, 2014 and January 5, 2015, 12 patients were enrolled in the phase 1 a study. The pharmacokinetics of HLX01 showed dose proportionality and accumulation to steady state. HLX01 was well tolerated, with no serious adverse events(AEs), discontinuations or DLTs. Between November 8, 2014 and August13, 2015, 87 eligible patients were enrolled in the phase 1 b study, including 43 who received HLX01 and 44 who were treated with rituximab-CN. The equivalence endpoint was met with GLSMR for AUC0-91 d being 89.6%(90% CI: 80.4%-99.8%). AEs, anti-drug antibodies, and CD19+ and CD20+ B lymphocyte counts were similar between the HLX01 and rituximab-CN treatment groups.Conclusions: Treatment with HLX01 was safe and well tolerated in Chinese patients with B-cell lymphoma.HLX01 and rituximab-CN have similar pharmacokinetic, pharmacodynamic and safety profiles. | Yuankai Shi Qingyuan Zhang Xiaohong Han Yan Qin Xiaoyan Ke Hang Su Li Liu Jinxiang Fu Jie Jin Jifeng Feng Xiaonan Hong Xiaohong Zhang Depei Wu Bin Jiang Xiaodong Dong | 2021 | Chinese Journal of Cancer Research2021，33，3： | 5 |
| 2 | 国际生物类似药研发审批和监管的进展显示文摘'生物类似药'(biosimilar)这一术语指的是生物制品的后续产品,与原研药之间有极高的相似性或可比性,通常生物类似药被批准用于与原研药相同的适应症。因为原研药的治疗费用高昂,使得应用受限,不能满足医疗需求。使用生物类似药不仅可降低治疗费用,也便于推广。虽然美国食品药物管理局(FDA)最早提出规范监管可比性的观念,但是欧洲药监局(EMA)首先将其应用于生物类似药,现在美国FDA(2012)也为生物类似药出台了指南草案,以规范审批流程。值得关注的是,从现在开始,现有的复杂生物制品,尤其是单克隆抗体的专利逐渐到期,使这些重要的原研药的生物类似药正处于全球制药行业药物研发的前列。这些将获得批准的新生物类似药对促进患者治疗和获得高品质的生物药物至关重要。 | 郭玮 王兰 高凯 | 2014 | 中国新药杂志2014，23，20： | 5 |
| 3 | Bevacizumab biosimilar LY01008 compared with bevacizumab(Avastin)as first-line treatment for Chinese patients with unresectable,metastatic,or recurrent non-squamous non-small-cell lung cancer:A multicenter,randomized,double-blinded,phase Ⅲ trial显示文摘Background:Previous studies have demonstrated the preclinical pharmacological and toxicological consistency,and clinical pharmacokinetic equivalence of bevacizumab biosimilar LY01008 with reference bevacizumab(Avastin).This randomized controlled trial aimed to compare the efficacy and safety of LY01008 with Avastin in first-line treatment of Chinese patients with advanced or recurrent non-squamous non-small cell lung cancer(NSCLC).Methods:StageⅢB-ⅣNSCLC patients with evaluable lesions,good physical status,and adequate organ functions from 67 centers across China were randomized in a ratio of 1:1 to receive LY01008 or Avastin 15 mg/kg intravenously in combination with paclitaxel/carboplatin(combined treatment)for 4-6 cycles,followed by maintenance monotherapy with LY01008 until disease progression,intolerable toxicity,or death.The primary endpoint was objective response rate(ORR)in accordance with Response Evaluation Criteria in Solid Tumors(RECIST)version 1.1 confirmed by independent radiological review committees(IRRC).Secondary endpoints included disease control rate(DCR),duration of response(DoR),progression-free survival(PFS),overall survival(OS),and safety.This study was registered in Clinical Trials.gov(NCT03533127).Results:Between December 15^(th),2017,and May 15^(th),2019,a total of 649 patients were randomized to the LY01008(n=324)or Avastin(n=325)group.As of September 25th,2019 for primary endpoint analysis,589 patients received ORR evaluation,with a median number of combined treatment cycles of 5(range 1-6)andmedian duration of treatment of 3.0(range 0.0-5.1)months.ORRof responseevaluable patients in the LY01008 and Avastin groups were 48.5% and 53.0%,respectively.The stratified ORR ratio was 0.91(90%CI 0.80-1.04,within the prespecified equivalence margin of 0.75-1.33).Up to May 15^(th),2020,with a median follow-up of 13.6(range 0.8-28.4)months,no notable differences in DCR,median DoR,median PFS,median OS,and 1-year OS rate were observed between the LY01008 and Avastin groups.There were no clinically meaningful differences in safety and immunogenicity across treatment groups.Conclusions:LY01008 demonstrated similarity to Avastin in terms of efficacy and safety in Chinese patients with advanced or recurrent non-squamous NSCLC.LY01008 combined with paclitaxel/carboplatin is expected to become a new treatment option for unresectable,metastatic,LY01008 and Avastin groups.There were no clinically meaningful differences in safety and immunogenicity across treatment groups.Conclusions:LY01008 demonstrated similarity to Avastin in terms of efficacy and safety in Chinese patients with advanced or recurrent non-squamous NSCLC.LY01008 combined with paclitaxel/carboplatin is expected to become a new treatment option for unresectable,metastatic,or recurrent non-squamous NSCLC patients in the first-line setting. | Yuankai Shi Kaijian Lei Yuming Jia Bingqiang Ni Zhiyong He Minghong Bi Xicheng Wang Jianhua Shi Ming Zhou Qian Sun Guolei Wang Dongji Chen Yongqian Shu Lianke Liu Zhongliang Guo Yong Liu Junquan Yang Ke Wang Ke Xiao LinWu Tienan Yi Debin Sun Mafei Kang Tianjiang Ma Yimin Mao Jinsheng Shi Tiegang Tang Yan Wang Puyuan Xing Dongqing Lv Wangjun Liao Zhiguo Luo Bin Wang Xiaohong Wu Xiaoli Zhu Shuhua Han Qisen Guo Rongyu Liu Zhiwei Lu Jianyong Zhang Jian Fang Changlu Hu Yinghua Ji Guolong Liu Hong Lu Dedong Wu Junhong Zhang Shuyang Zhu Zheng Liu Wensheng Qiu Feng Ye Yan Yu Yanqiu Zhao Qinhong Zheng Jun Chen Zhanyu Pan Yiping Zhang Wenjuan Lian Bo Jiang Bo Qiu Guojun Zhang Hua Zhang Yanju Chen Yuan Chen Hongbing Duan Manxiang Li Shengming Liu Lijun Ma Hongming Pan Xia Yuan Xueli Yuan Yulong Zheng Emei Gao Li Zhao Shumin Wang Can Wu | 2021 | Cancer Communications2021，41，9： | 5 |
| 4 | Equivalent efficacy study of QL1101 and bevacizumab on untreated advanced non-squamous non-small cell lung cancer patients: a phase 3 randomized, double-blind clinical trial显示文摘Objective:This phase 3 study aimed to test equivalence in efficacy and safety for QL1101,a bevacizumab analogue in Chinese patients with untreated locally advanced non-squamous non-small cell lung cancer(NSCLC).Methods:Eligible patients were randomly assigned 1:1 to receive carboplatin and paclitaxel in combination with either QL1101 or bevacizumab,15 mg/kg every 3-week for 6 cycles.This was followed by maintenance treatment with single agent QL1101 every 3-week.The primary end-point was objective response rate(ORR),with secondary end-points being progression-free survival(PFS),overall survival(OS),disease control rate(DCR),and adverse events(AEs).Results:Of 675 patients,535 eligible patients were randomized to the QL1101 group(n=269)and bevacizumab group(n=266).ORRs were 52.8%and 56.8%,respectively,for the QL1101 and bevacizumab groups,with an ORR hazard ratio 0.93(95%confidence interval:0.8-0131.1).The PFS,OS,DCR,and AEs were comparable between the 2 groups,which remained the same after stratification according to epidermal growth factor receptor mutation or smoking history.Conclusions:QL1101 showed similar efficacy and safety profiles as compared to bevacizumab among Chinese patients with untreated locally advanced non-squamous NSCLC. | Tianqing Chu Jun Lu Minghong Bi Helong Zhang Wu Zhuang Yan Yu Jianhua Shi Zhendong Chen Xiaochun Zhang Qisen Guo Quan Liu Huijuan Wu Jian Fang Yi Hu Xiuwen Wang Cuicui Han Kai Li Baohui Han | 2021 | Cancer Biology & Medicine2021，18，3： | 4 |
| 5 | Equivalent efficacy assessment of QL1101 and bevacizumab in nonsquamous non-small cell lung cancer patients:A two-year follow-up data update显示文摘Objective: Anti-vascular endothelial growth factor(VEGF) monoclonal antibodies are an effective means of treating non-small cell lung cancer(NSCLC). Here, we aim to update the equivalent efficacy assessment between QL1101 and bevacizumab based on two-year follow-up data.Methods: In total, 535 eligible NSCLC patients were enrolled in this randomized controlled trial. Patients were randomly assigned 1:1 to the QL1101 group and the bevacizumab group. The full end time of this study was defined as 24 months after the last enrolled patient was randomized. The primary endpoint was the objective response rate(ORR);equivalence was confirmed if the two-sided 90% confidence interval(90% CI) of the relative risk was within the range of 0.75-1.33. The secondary endpoints were progression-free survival(PFS) and overall survival(OS).Results: The two-year updated data showed similar ORR(QL1101 vs. bevacizumab: 53.1% vs. 54.3%;relative risk=0.977;90% CI: 0.838-1.144), PFS(235 d vs. 254 d, log-rank P=0.311), and OS(577 d vs. 641 d, log-rank P=0.099) results between the QL1101 group and the bevacizumab group. The mean shrinkage ratio of targeted lesions was also similar between the QL1101 group and the bevacizumab group(22.5% vs. 23.5%). For patients who received QL1101 maintenance therapy, similar results were shown between the QL1101 group(n=157) and the bevacizumab group(n=148)(PFS: 253 d vs. 272 d, log-rank P=0.387;OS: 673 d vs. 790 d, log-rank P=0.101;mean tumor shrinkage rate: 26.6% vs. 27.5%).Conclusions: This study reported that QL1101 had similar efficacy in treating nonsquamous NSCLC in terms of ORR, PFS and OS based on two-year updated data, providing a basis for the clinical application of QL1101. | Jun Lu Tianqing Chu Hongyu Liu Minjuan Hu Yuqing Lou Yanwei Zhang Zhiqiang Gao Wei Zhang Xueyan Zhang Huimin Wang Hua Zhong Baohui Han | 2022 | Chinese Journal of Cancer Research2022，34，1： | 1 |
| 6 | Monoclonal antibody:the corner stone of modern biotherapeutics显示文摘Worldwide sales of biologic drugs exceeded 100 billion USD in 2011.About 32% is from therapeutic monoclonal antibody(mAb).With many blockbuster biopharmaceutical patents expiring over the next decade,there is a great opportunity for biosimilar to enter the worldwide especially emerging market.Both European Medicines Agency(EMA) and Food and Drug Administration(FDA) have introduced regulatory frameworks for the potential approval of biosimilar mAb therapeutics.Rather than providing a highly abbreviated path,as in the case for small molecule chemical drug,approval for biosimilar mAb will require clinical trial and the details will be very much on a case-by-case basis.Since mAb is the dominant category of biologic drugs,mAb will be the focus of this review.First,the United States(US) and European Union(EU) approved mAb and those in phase 3 trials will be reviewed,then strategies on how to win biosimilar competition will be reviewed. | XIA Zhi-nan CAI Xue-ting CAO Peng | 2012 | 药学学报2012，47，10： | 1 |
| 7 | Insights on the use of biosimilars in the treatment of inflammatory bowel disease显示文摘Biologic therapy, such as those that target tumor necrosis factor(TNF) signaling, has proven to be an efficacious method of treatment for patients with inflammatory bowel disease(IBD) with regards to symptom management and mucosal healing. However, the rising prevalence of IBD worldwide and the everincreasing burden of biologic pharmaceuticals in the health care industry is alarming for insurance companies, clinicians, and patients. The impending patent expiry and the relatively high costs of biologics, particularly anti-TNF agents, have paved the way for biosimilar development for IBD. The United States Food and Drug Administration defines a biosimilar as a biological product that is highly similar to its reference medicinal product, with no clinically meaningful differences in terms of safety, purity, and potency. The hope with biosimilars is that their entry into the market will be able to drive competition between pharmaceutical companies to reduce prices like that of the generic market, and that access to appropriate biologic treatments for IBD patients is increased in the long-term. Yet, there are challenging issues such as indication extrapolation and interchangeability that are still being debated in the field of IBD and must be addressed in future issued guidance. This review will discuss the issues and implications concerning the use of biosimilar therapy for IBD. | Michael K Zheng David Q Shih Gary C Chen | 2017 | World Journal of Gastroenterology2017，23，11： | 1 |
| 8 | Challenges of modern day transition care in inflammatory bowel disease: From inflammatory bowel disease to biosimilars显示文摘In this article we discuss the challenges of delivering a high quality Transition care. A good understanding of the adolescent needs with good communication between Transition care physicians and the patient is essential for good continuity of care. Despite availability of several guidelines, one model doesn't fit all and any transition service development should be determined by the local need and available healthcare facilities. | Ali Hakizimana Iftikhar Ahmed Rachel Russell Mark Wright Nadeem A Afzal | 2017 | World Journal of Gastroenterology2017，23，25： | 0 |
| 9 | Loss of efficacy and safety of the switch from infliximab original to infliximab biosimilar(CT-P13)in patients with inflammatory bowel disease显示文摘BACKGROUND Infliximab original has changed the natural history of inflammatory bowel diseases(IBD) over the past two decades. However, the recent expiration of its patent has allowed the entry of the first Infliximab biosimilar into the European and Spanish markets. Currently switching drugs data in IBD are limited. AIM To compare the efficacy of infliximab biosimilar, CT-P13, against infliximab original, analyzing the loss of response of both at the 12 mo follow-up in patients with IBD.METHODS An observational study of two cohorts has been conducted. One retrospective cohort that included patients with IBD treated with Infliximab original, and a prospective cohort of patients who were switching from infliximab original to infliximab biosimilar(CT-P13). We had analyzed the overall efficacy and loss of efficacy in patients in remission at the end of one year after treatment with the original drug compared to the results of the year of treatment with the biosimilar.RESULTS98 patients(CD 67, CU 31) were included in both cohorts. The overall efficacy for infliximab original per year of treatment was 71% vs 68.2% for infliximab biosimilar(P = 0.80). The loss of overall efficacy at 12 mo for infliximab original was 6.6% vs 14.5% for infliximab biosimilar(P = 0.806). The loss of efficacy in patients who were in basal remission was 16.3% for infliximab original vs 27.1% for infliximab biosimilar. Adverse events were 9.2% for infliximab original vs 11.2% for infliximab biosimilar. CONCLUSION The overall efficacy and loss of treatment response with infliximab biosimilar(CT-P13) is similar to that observed with infliximab original in patients who were switching at the 12 mo follow-up. There is no difference in the rate of adverse events. | María Fernanda Guerra Veloz Federico Argüelles-Arias Luisa Castro Laria Belén Maldonado Pérez Antonio Benítez Roldan Raúl Perea Amarillo Vicente Merino Bohórquez Miguel Angel Calleja Angel Caunedo Alvarez Angel Vilches Arenas | 2018 | World Journal of Gastroenterology2018，24，46： | 0 |
| 10 | Real-world data on the infliximab biosimilar CT-P13 (Remsima®) in inflammatory bowel disease显示文摘BACKGROUND In recent years,biological therapies have revolutionized the management of inflammatory bowel disease(IBD);however,they are expensive.The development of biosimilar products has allowed us to reduce healthcare costs and improve patients’access to these treatments.Although various studies support the similarity between infliximab and its biosimilar CT-P13 in terms of efficacy and safety,there are unmet needs regarding research on these agents in the context of IBD.AIM To analyze clinical response rates to CT-P13 and adverse events in IBD patients treated in real-life practice.METHODS An observational,prospective,multicenter study of IBD patients treated with CTP13 in clinical practice who were naïve to biological treatments or failed to respond to other anti-tumor necrosis factor drugs or had switched from infliximab originator was carried out.No diagnostic or follow-up interventions were conducted on patients outside usual clinical practice.The primary endpoints were clinical response rates and number of adverse events.The primary efficacy variable was the proportion of patients who were in clinical remission and/or had a clinical response at 3,6,9,and 12 mo.RESULTS A total of 220 IBD patients treated with CT-P13(Remsima®)were included in the study:87(40%)with ulcerative colitis and 133(60%)with Crohn’s disease.Mean age of the patients was 41.47(SD 15.74)years,and 58%were female.Nineteen(9%)patients started treatment with CT-P13 after switching from infliximab.Of the remaining 201 patients,142(65%)were naïve to biologic agents.At baseline,68.6%(n=138/201)of patients presented with active disease.After 12 mo of treatment,14.8%(n=12/81)presented with active disease,and 64.2%(n=52/81)were in clinical remission without corticosteroids.After 3 mo,75.5%(n=115/152)had a clinical response or achieved clinical remission,which was sustained for 12 mo(85.2%;n=69/81).There was a decrease in specific IBD indices at 3,6,9,and 12 mo(P<0.001).A total of 34 adverse events were reported by 27(12.3%)patients,9(26.5%)of which were serious.CONCLUSION CT-P13 is an effective and safe infliximab biosimilar for the treatment of IBD in real-life practice and may be a valid and attractive alternative for the treatment of IBD. | Jose María Huguet Xavier Cortés Marta Maia Bosca-Watts Marian Aguas Nuria Maroto Lidia Martí Cirilo Amorós Jose María Paredes | 2021 | World Journal of Clinical Cases2021，9，36： | 0 |
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