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Introductory Chapter: Biosimilars - A Regulatory and Clinical Perspective
Efficacy of HD201 vs Referent Trastuzumab in Patients With ERBB2-Positive Breast Cancer Treated in the Neoadjuvant Setting: A Multicenter Phase 3 Randomized Clinical Trial.JAMA Oncology2022
Physicochemical stability of PF-05280014 (trastuzumab-qyyp; Trazimera), a trastuzumab biosimilar, under extended in-use conditions.Journal of Oncology Pharmacy Practice2022
Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution.PLoS ONE2022
Biosimilars for Psoriasis2021
Generic Medicines and Biosimilars: Impact on Global Pharmaceutical Policy2020
Representation of Proteins with Posttranslational Modifications in the HL7 SPL StandardMethods in Pharmacology and Toxicology2018
Statistical Applications for Biosimilar Product DevelopmentICSA Book Series in Statistics2016
Phase I/II study to assess the clinical pharmacology and safety of single ascending and multiple subcutaneous doses of PF-06881894 in women with non-distantly metastatic breast cancerCancer Chemotherapy and Pharmacology2021
Intravenous Epoetin Alfa-epbx versus Epoetin Alfa for Treatment of Anemia in End-Stage Kidney DiseaseClinical Journal of the American Society of Nephrology: CJASN2018
BIOSIMILARS IN RHEUMATOLOGYNauchno-Prakticheskaya Revmatologiya2017
Pharmacovigilance of Biosimilars: Global Experience and PerspectiveAAPS Advances in the Pharmaceutical Sciences Series2018
Immunogenicity Assessment of Biosimilars: A Multidisciplinary PerspectiveAAPS Advances in the Pharmaceutical Sciences Series2018
Role of Pharmacokinetics: Pharmacodynamics in Biosimilar Assessment2016
A Randomized Phase 1 Pharmacokinetic Study Comparing the Potential Biosimilar LRG201902 With Liraglutide (Victoza) in Healthy Male SubjectsFrontiers in Pharmacology2020
A randomized phase I study comparing the pharmacokinetics of a bevacizumab (HD204) biosimilar to European Union- and United States of America-sourced bevacizumabPLoS ONE2021
Pharmacokinetic bioequivalence, safety, and immunogenicity of GB222, a bevacizumab biosimilar candidate, and bevacizumab in Chinese healthy males: a randomized clinical trialExpert Opinion on Biological Therapy2021
Analytical Similarity Assessment of ABP 959 in Comparison with Eculizumab Reference ProductBioDrugs2021
A Randomized, Double-Blind, Single-Dose Study Comparing the Biosimilarity of HOT-1010 With Bevacizumab (Avastin®) in Chinese Healthy Male SubjectsFrontiers in Pharmacology2021
A phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX04 to reference bevacizumab sourced from the United States, the European Union, and China in healthy Chinese male volunteersCancer Chemotherapy and Pharmacology2021
A Biosimilarity Study Between QX001S and Ustekinumab in Healthy Chinese Male SubjectsFrontiers in Pharmacology2021
Design and Analysis of a Biosimilar Bridging Study with a Prediction Interval-Based Consistency TestTherapeutic Innovation and Regulatory Science2021
A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumabJournal of Cancer Research and Clinical Oncology2021
Efficacy, Safety and Immunogenicity of MB02 (Bevacizumab Biosimilar) versus Reference Bevacizumab in Advanced Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study (STELLA)BioDrugs2021
A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of HOT-3010 to Adalimumab Among Healthy Chinese Male SubjectsFrontiers in Pharmacology2021
Safety and pharmacokinetics of a new biosimilar trastuzumab (HL02): a Phase I bioequivalence study in healthy Chinese menExpert Opinion on Biological Therapy2021
A Phase I Clinical Study Comparing the Tolerance, Immunogenicity, and Pharmacokinetics of Proposed Biosimilar BAT1806 and Reference Tocilizumab in Healthy Chinese MenFrontiers in Pharmacology2020
A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (Actemra) in Chinese healthy subjectsAnnals of Medicine2021
Update of the Position Paper of the Spanish Society of Rheumatology on Biosimilar DrugsReumatología Clínica2021
The Totality of Evidence and Use of ABP 215, a Biosimilar to BevacizumabOncology and Therapy2021
Safety and pharmacokinetics of a biosimilar of denosumab (KN012): Phase 1 and bioequivalence study in healthy Chinese subjectsExpert Opinion on Investigational Drugs2021
A large multicentre, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologicsBritish Journal of Clinical Pharmacology2020
Analytical Similarity of a Proposed Biosimilar BVZ-BC to BevacizumabAnalytical Chemistry2020
Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54-78 Data From a Randomized, Double-Blind, Phase III TrialBioDrugs2020
Mobilization of Hematopoietic Stem Cells into Peripheral Blood for Autologous Transplantation Seems Less Efficacious in Poor Mobilizers with the Use of a Biosimilar of Filgrastim and Plerixafor: A Retrospective Comparative AnalysisOncology and Therapy2020
A randomized, double-blind, single-dose, three-arm, parallel group study to determine pharmacokinetic similarity of ABP 959 and eculizumab (Soliris ) in healthy male subjectsEuropean Journal of Haematology2020
Biosimilar Drug Development2020
PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy VolunteersAdvances in Therapy2020
A randomized Phase I pharmacokinetic trial comparing the potential biosimilar trastuzumab (SIBP-01) with the reference product (Herceptin®) in healthy Chinese male volunteersExpert Opinion on Drug Metabolism and Toxicology2020
Efficacy and safety results from a randomized double-blind study comparing proposed biosimilar ABP 798 with rituximab reference product in subjects with moderate-to-severe rheumatoid arthritisClinical Rheumatology2020
A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy SubjectsFrontiers in Pharmacology2020
Biologic Drug Quality Assurance to Optimize HER2 + Breast Cancer Treatment: Insights from Development of the Trastuzumab Biosimilar SB3Targeted Oncology2020
A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL)BioDrugs2020
Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory DocumentsBioDrugs2020
Laboratory Monitoring of Biological Therapies in Rheumatology: The Role of ImmunogenicityAnnals of Laboratory Medicine2020
Biophysical characterization2020
Worldwide Network for Blood and Marrow Transplantation (WBMT) perspective: the role of biosimilars in hematopoietic cell transplant: current opportunities and challenges in low- and lower-middle income countriesBone Marrow Transplantation2020
Lilly Insulin Glargine Versus Lantus in Insulin-Naïve and Insulin-Treated Adults with Type 2 Diabetes: A Randomized, Controlled Trial (ELEMENT 5)Diabetes Therapy2019