| Introductory Chapter: Biosimilars - A Regulatory and Clinical Perspective | | |
| Biosimilars | Turkderm | |
| DataSheet_1.docx | | 2020 |
| 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 Oncology | 2022 |
| Physicochemical stability of PF-05280014 (trastuzumab-qyyp; Trazimera), a trastuzumab biosimilar, under extended in-use conditions. | Journal of Oncology Pharmacy Practice | 2022 |
| Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution. | PLoS ONE | 2022 |
| Biosimilars for Psoriasis | | 2021 |
| Generic Medicines and Biosimilars: Impact on Global Pharmaceutical Policy | | 2020 |
| Representation of Proteins with Posttranslational Modifications in the HL7 SPL Standard | Methods in Pharmacology and Toxicology | 2018 |
| Statistical Applications for Biosimilar Product Development | ICSA Book Series in Statistics | 2016 |
| 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 cancer | Cancer Chemotherapy and Pharmacology | 2021 |
| Intravenous Epoetin Alfa-epbx versus Epoetin Alfa for Treatment of Anemia in End-Stage Kidney Disease | Clinical Journal of the American Society of Nephrology: CJASN | 2018 |
| BIOSIMILARS IN RHEUMATOLOGY | Nauchno-Prakticheskaya Revmatologiya | 2017 |
| Pharmacovigilance of Biosimilars: Global Experience and Perspective | AAPS Advances in the Pharmaceutical Sciences Series | 2018 |
| Immunogenicity Assessment of Biosimilars: A Multidisciplinary Perspective | AAPS Advances in the Pharmaceutical Sciences Series | 2018 |
| Role of Pharmacokinetics: Pharmacodynamics in Biosimilar Assessment | | 2016 |
| A Randomized Phase 1 Pharmacokinetic Study Comparing the Potential Biosimilar LRG201902 With Liraglutide (Victoza) in Healthy Male Subjects | Frontiers in Pharmacology | 2020 |
| A randomized phase I study comparing the pharmacokinetics of a bevacizumab (HD204) biosimilar to European Union- and United States of America-sourced bevacizumab | PLoS ONE | 2021 |
| Pharmacokinetic bioequivalence, safety, and immunogenicity of GB222, a bevacizumab biosimilar candidate, and bevacizumab in Chinese healthy males: a randomized clinical trial | Expert Opinion on Biological Therapy | 2021 |
| Analytical Similarity Assessment of ABP 959 in Comparison with Eculizumab Reference Product | BioDrugs | 2021 |
| A Randomized, Double-Blind, Single-Dose Study Comparing the Biosimilarity of HOT-1010 With Bevacizumab (Avastin®) in Chinese Healthy Male Subjects | Frontiers in Pharmacology | 2021 |
| 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 volunteers | Cancer Chemotherapy and Pharmacology | 2021 |
| A Biosimilarity Study Between QX001S and Ustekinumab in Healthy Chinese Male Subjects | Frontiers in Pharmacology | 2021 |
| Design and Analysis of a Biosimilar Bridging Study with a Prediction Interval-Based Consistency Test | Therapeutic Innovation and Regulatory Science | 2021 |
| A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab | Journal of Cancer Research and Clinical Oncology | 2021 |
| 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) | BioDrugs | 2021 |
| A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of HOT-3010 to Adalimumab Among Healthy Chinese Male Subjects | Frontiers in Pharmacology | 2021 |
| Safety and pharmacokinetics of a new biosimilar trastuzumab (HL02): a Phase I bioequivalence study in healthy Chinese men | Expert Opinion on Biological Therapy | 2021 |
| A Phase I Clinical Study Comparing the Tolerance, Immunogenicity, and Pharmacokinetics of Proposed Biosimilar BAT1806 and Reference Tocilizumab in Healthy Chinese Men | Frontiers in Pharmacology | 2020 |
| A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (Actemra) in Chinese healthy subjects | Annals of Medicine | 2021 |
| Update of the Position Paper of the Spanish Society of Rheumatology on Biosimilar Drugs | Reumatología Clínica | 2021 |
| The Totality of Evidence and Use of ABP 215, a Biosimilar to Bevacizumab | Oncology and Therapy | 2021 |
| Safety and pharmacokinetics of a biosimilar of denosumab (KN012): Phase 1 and bioequivalence study in healthy Chinese subjects | Expert Opinion on Investigational Drugs | 2021 |
| 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 biologics | British Journal of Clinical Pharmacology | 2020 |
| Analytical Similarity of a Proposed Biosimilar BVZ-BC to Bevacizumab | Analytical Chemistry | 2020 |
| 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 Trial | BioDrugs | 2020 |
| 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 Analysis | Oncology and Therapy | 2020 |
| A randomized, double-blind, single-dose, three-arm, parallel group study to determine pharmacokinetic similarity of ABP 959 and eculizumab (Soliris ) in healthy male subjects | European Journal of Haematology | 2020 |
| Biosimilar Drug Development | | 2020 |
| 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 Volunteers | Advances in Therapy | 2020 |
| A randomized Phase I pharmacokinetic trial comparing the potential biosimilar trastuzumab (SIBP-01) with the reference product (Herceptin®) in healthy Chinese male volunteers | Expert Opinion on Drug Metabolism and Toxicology | 2020 |
| 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 arthritis | Clinical Rheumatology | 2020 |
| A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy Subjects | Frontiers in Pharmacology | 2020 |
| Biologic Drug Quality Assurance to Optimize HER2 + Breast Cancer Treatment: Insights from Development of the Trastuzumab Biosimilar SB3 | Targeted Oncology | 2020 |
| 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) | BioDrugs | 2020 |
| Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents | BioDrugs | 2020 |
| Laboratory Monitoring of Biological Therapies in Rheumatology: The Role of Immunogenicity | Annals of Laboratory Medicine | 2020 |
| Biophysical characterization | | 2020 |
| 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 countries | Bone Marrow Transplantation | 2020 |
| Lilly Insulin Glargine Versus Lantus in Insulin-Naïve and Insulin-Treated Adults with Type 2 Diabetes: A Randomized, Controlled Trial (ELEMENT 5) | Diabetes Therapy | 2019 |
