Article
Pharmacology & Pharmacy
Gang Mai, Lianlian Fan, Mupeng Li, Peiwen Zhang, Chunyan Gan, Qian Huang, Jianzhong Shentu
Summary: The study demonstrated pharmacokinetic similarity between LRG201902 and Victoza(R) in healthy subjects, with comparable safety and immunogenicity profiles in the two products.
FRONTIERS IN PHARMACOLOGY
(2021)
Article
Biochemistry & Molecular Biology
Yanli Wang, Zhengzhi Liu, Qiaohuan Deng, Zhengjie Su, Jinling Xue, Yicheng Zhao, Haimiao Yang
Summary: This study compared the pharmacokinetics, immunogenicity and safety of trastuzumab and its biosimilar in healthy Chinese subjects. The results showed that both drugs had similar pharmacokinetic profiles and met the bioequivalence standards. No serious adverse events or immunogenicity were reported, and the adverse events reported were mild and similar between the two treatment groups.
EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY
(2023)
Article
Multidisciplinary Sciences
Martin Demarchi, Pierre Coliat, Philippe Barthelemy, Roland Schott, Meher BenAbdelghani, Michael Kim, Jocelyn Chung Shii Hii, Peggy Feyaerts, Felicia Rui Xia Ang, Marie Paule Derde, Filip Deforce, Thierry Petit, Chris Schwabe, Chris Wynne, Lisa Soyeon Park, Xavier Pivot
Summary: This study demonstrated the pharmacokinetic equivalence of HD204 compared to US-sourced and EU-sourced bevacizumab, with all PK parameters falling within the predefined equivalence margin of 80% to 125%. The results support the comparable PK properties of all three treatment groups, including AUC(0-inf), AUC(0-last), and C-max ratios.
Article
Chemistry, Medicinal
Parag Goyal, Jyoti Iyer, Laxmi Adhikary, Bhavesh Vats, Pradeep Kabadi, Harish Pai, Daniel Ranayhossaini, Shankara Gouda, Malini Subbarao, Gaurav Mehta, Arindam Saha, Arnab Bera, Abhilashi Sahu, Maninder Kaur, Ankita Singh, Ashwani Marwah, Praveen Kumar Reddy Moole, Jeffrey Smith, Ramakrishnan Melarkode, Rajesh Ullanat
Summary: The study demonstrated high structural and functional similarity between trastuzumab-dkst and the Herceptin(R) biosimilar, showing equivalent effects on HER2(+) cells.
FUTURE MEDICINAL CHEMISTRY
(2021)
Article
Biotechnology & Applied Microbiology
Qin Zhang, Cheng Sun, Jinying Wu, Juan Wu, Xuan Zhang, Yueyue Liu, Changlin Dou, Huilin Qin, Qian Zhang, Renpeng Zhou, Wei Hu
Summary: This study compared the pharmacokinetic profiles, safety, and immunogenicity of LY05008, a dulaglutide biosimilar, to dulaglutide in healthy Chinese male subjects. The results showed that LY05008 was similar to dulaglutide in terms of PK parameters, safety, and immunogenicity.
EXPERT OPINION ON BIOLOGICAL THERAPY
(2023)
Article
Medicine, General & Internal
Hong Zhang, Xiaojiao Li, Jingrui Liu, Cuiyun Li, Min Wu, Xiaoxue Zhu, Jixuan Sun, Min Fang, Yanhua Ding
Summary: QX003S showed similar pharmacokinetics and immunogenicity to the reference product Actemra (R) in healthy Chinese male subjects, with both groups experiencing mild to moderate adverse effects.
ANNALS OF MEDICINE
(2021)
Article
Rheumatology
Josef S. Smolen, Stanley B. Cohen, Hans-Peter Tony, Morton Scheinberg, Alan Kivitz, Andra Balanescu, Juan Gomez-Reino, Liyi Cen, Johann Poetzl, Tamas Shisha, Dmitrij Kollins
Summary: In the 52-week ASSIST-RA study, SDZ-RTX demonstrated similar B cell concentrations over time, efficacy, safety and immunogenicity to Ref-RTX.
Article
Pharmacology & Pharmacy
Hanjing Chen, Weili Chen, Fei Yuan, Qingcheng Guo, Xunmin Zhang, Chenguang Wang, Xuening Li
Summary: This study evaluated the bioequivalence of CMAB807, a biosimilar to denosumab, for the treatment of osteoporosis. The results showed that CMAB807 had similar pharmacokinetics, pharmacodynamics, safety, and immunogenicity to denosumab. CMAB807 could potentially be a new treatment option for patients with osteoporosis.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Pharmacology & Pharmacy
Guoying Cao, Jingjing Wang, Jinjie He, Yingying Hu, Haijing Yang, Linling Que, Xianghong Gu, Jicheng Yu, Xiaojie Wu, Jufang Wu, Wei Fang, Qing He, Jing Zhang
Summary: This study aimed to investigate the pharmacokinetics, safety, and immunogenicity of LZM008 and evaluate its similarity to wtocilizumab in Chinese healthy male subjects. The results showed that LZM008 exhibited similar pharmacokinetic characteristics and safety profiles to the reference product, ACTEMRA (R).
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Pharmacology & Pharmacy
Yingzi Cui, Dongyang Cui, Xinran Ren, Xuesong Chen, Guangwen Liu, Zhengzhi Liu, Yanli Wang, Xinyao Qu, Yicheng Zhao, Haimiao Yang
Summary: The pharmacokinetics, immunogenicity, and safety of the biosimilar SHR-1309 injection and the original drug Perjeta (R) were compared in healthy Chinese male subjects in a study. The results showed that SHR-1309 was bioequivalent to Perjeta (R) with similar immunogenicity and safety profiles.
FRONTIERS IN PHARMACOLOGY
(2021)
Article
Biotechnology & Applied Microbiology
Wenjia Zhou, Meng Wang, Yunli Yu, Ji Wang, Yanni Wu, Guiyu Yang, Haoyu Yu, Jing Li, Liang Zhou, Quanying Zhang
Summary: This study evaluated the bioequivalence between HLX02 and US-approved trastuzumab. The results showed that HLX02 is bioequivalent to both US-trastuzumab and EU-trastuzumab, with similar safety and immunogenicity profiles.
EXPERT OPINION ON BIOLOGICAL THERAPY
(2023)
Article
Medicine, Research & Experimental
Hong Tang, Francesca Civoli, Suzanna Tatarewicz, Nathalie Vandenkoornhuyse, Barbara Finck
Summary: This study assessed the impact of the autoinjector and prefilled syringe administration methods on the pharmacokinetics and pharmacodynamics of pegfilgrastim-cbqv and evaluated their safety. The results showed similar bioequivalence between the two administration methods and similar side effects. This suggests that administering pegfilgrastim-cbqv with the autoinjector is comparable to using the prefilled syringe in terms of effectiveness and safety.
ADVANCES IN THERAPY
(2023)
Article
Chemistry, Medicinal
Meng-Na Wang, Hai-Tao Yu, Ya-Qian Li, Yun Zeng, Shuang Yang, Guo-Ping Yang, Qi Pei, Jie Huang
Summary: The study demonstrated the bioequivalence of a generic form of obeticholic acid and the reference drug in healthy Chinese subjects under both fasting and fed conditions, with no significant adverse events reported. Food intake may impact the main pharmacokinetic parameters of the two preparations.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2021)
Article
Immunology
Jason D. Lickliter, Rakesh Naranbhai Dadhania, Ravi Kumar Trivedi, S. R. Naveen Kumar, Pramod Kumar Reddy
Summary: This study demonstrated that DRL_TZ showed pharmacokinetic equivalence with RMP and had comparable safety and immunogenicity profiles in healthy adult male subjects.
INDIAN JOURNAL OF MEDICAL RESEARCH
(2021)
Article
Pharmacology & Pharmacy
Christopher Wynne, Paul Hamilton, Kristi McLendon, Heimo Stroissnig, Matthew Smith, Paul Duijzings, Ruth Ruffieux, Hendrik Otto, Abid Sattar, Halimu N. Haliduola, Steffen Leutz, Fausto Berti
Summary: This study assessed the pharmacokinetic similarity, safety, and immunogenicity of candidate biosimilar AVT04 compared with reference product ustekinumab. The results showed that AVT04 demonstrated pharmacokinetic similarity with EU-RP and US-RP, and had similar safety and immunogenicity profiles.
EXPERT OPINION ON INVESTIGATIONAL DRUGS
(2023)