Systematic Review on the Use of Biosimilars of Trastuzumab in HER2+ Breast Cancer | | 2022 |
Non-Medical Switching in Dermatology: Cost-Conscious Policy or an Affront to Patient Safety? | | |
Introductory Chapter: Biosimilars - A Regulatory and Clinical Perspective | | |
Biosimilars in der pädiatrischen Rheumatologie | Springer Reference Medizin | 2022 |
Comparison of Three Complementary Analytical Techniques for the Evaluation of the Biosimilar Comparability of a Monoclonal Antibody and an Fc-Fusion Protein. | Frontiers in Chemistry | 2021 |
Evaluation of physicochemical and functional similarity of a new CHO derived anti-EGFR antibody P-mAb to its reference medicinal product. | Artificial Cells, Nanomedicine and Biotechnology | 2022 |
Biosimilars for Psoriasis | | 2021 |
Interchangeability Study Design and Analysis | AAPS Advances in the Pharmaceutical Sciences Series | 2018 |
Insights on the use of biosimilars in the treatment of inflammatory bowel disease | World Journal of Gastroenterology | 2017 |
BIOSIMILARS IN RHEUMATOLOGY | Nauchno-Prakticheskaya Revmatologiya | 2017 |
Immunogenicity Assessment of Biosimilars: A Multidisciplinary Perspective | AAPS Advances in the Pharmaceutical Sciences Series | 2018 |
Statistical Considerations for Demonstration of Analytical Similarity | 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 pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab | Journal of Cancer Research and Clinical Oncology | 2021 |
Pharmacokinetic equivalence of CT-P17 to high-concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects | Clinical and Translational Science | 2021 |
A Phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX02 to reference CN- and EU-sourced trastuzumab in healthy subjects | Cancer Chemotherapy and Pharmacology | 2021 |
The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases | Drugs | 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 |
Biosimilar Drug Development | | 2020 |
Biologic Drug Quality Assurance to Optimize HER2 + Breast Cancer Treatment: Insights from Development of the Trastuzumab Biosimilar SB3 | Targeted Oncology | 2020 |
Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents | BioDrugs | 2020 |
Anti-tumor necrosis factor biosimilars and intended copies in rheumatology: Perspective from the Asia Pacific region | International Journal of Rheumatic Diseases | 2019 |
Regulation of biosimilar medicines and current perspectives on interchangeability and policy | European Journal of Clinical Pharmacology | 2019 |
Long-Term Efficacy and Safety of Biosimilar CT-P10 Versus Innovator Rituximab in Rheumatoid Arthritis: 48-Week Results from a Randomized Phase III Trial | BioDrugs | 2019 |
Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia | Annals of Hematology | 2019 |
Adalimumab Biosimilars in Europe: An Overview of the Clinical Evidence | BioDrugs | 2019 |
Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey | Pharmacoepidemiology and Drug Safety | 2019 |
Genetic engineering approaches to improve posttranslational modification of biopharmaceuticals in different production platforms | Biotechnology and Bioengineering | 2019 |
Biological Characterization of SB3, a Trastuzumab Biosimilar, and the Influence of Changes in Reference Product Characteristics on the Similarity Assessment | BioDrugs | 2019 |
Era of biosimilars in rheumatology: reshaping the healthcare environment | RMD Open | 2019 |
Aptamers as quality control tool for production, storage and biosimilarity of the anti-CD20 biopharmaceutical rituximab | Scientific Reports | 2019 |
GP2017, an adalimumab biosimilar: pharmacokinetic similarity to its reference medicine and pharmacokinetics comparison of different administration methods | Expert Opinion on Biological Therapy | 2019 |
Sensitivity of Pegfilgrastim Pharmacokinetic and Pharmacodynamic Parameters to Product Differences in Similarity Studies | AAPS Journal | 2019 |
Bioengineering of rFVIIa Biopharmaceutical and Structure Characterization for Biosimilarity Assessment | Bioengineering | 2018 |
Biosimilars are coming: ready or not | Internal Medicine Journal | 2018 |
A comparative pharmacokinetic study of DRL_BZ, a candidate biosimilar of bevacizumab, with Avastin (EU and US) in healthy male subjects | British Journal of Clinical Pharmacology | 2018 |
Global Acceptance of Biosimilars: Importance of Regulatory Consistency, Education, and Trust | Oncologist | 2018 |
Efficacy and Safety Outcomes for Originator TNF Inhibitors and Biosimilars in Rheumatoid Arthritis and Psoriasis Trials: A Systematic Literature Review | BioDrugs | 2018 |
Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction | Drug Safety | 2018 |
Risk-Based Comparability Assessment for Monoclonal Antibodies During Drug Development: A Clinical Pharmacology Perspective | AAPS Journal | 2018 |
Development of New Formulations of Biologics: Expectations, Immunogenicity, and Safety for Subcutaneous Trastuzumab | Pharmaceutical Medicine | 2018 |
Efficacy, safety and immunogenicity of GP2015, an etanercept biosimilar, compared with the reference etanercept in patients with moderate-to-severe rheumatoid arthritis: 24-week results from the comparative phase III, randomised, double-blind EQUIRA study | RMD Open | 2018 |
Sample Size for Multiple Hypothesis Testing in Biosimilar Development | Statistics in Biopharmaceutical Research | 2018 |
The Role of Rituximab in Chronic Lymphocytic Leukemia Treatment and the Potential Utility of Biosimilars | Oncologist | 2018 |
Inappropriate claims from non-equivalent medications in osteoarthritis: a position paper endorsed by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) | Aging Clinical and Experimental Research | 2018 |
Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases | Annals of the Rheumatic Diseases | 2018 |
Phase III Randomized Study of SB5, an Adalimumab Biosimilar, Versus Reference Adalimumab in Patients With Moderate-to-Severe Rheumatoid Arthritis | Arthritis and Rheumatology | 2018 |
Variability of intended copies for etanercept (Enbrel®): Data on multiple batches of seven products | MAbs | 2018 |
Biosimilar Drugs for Psoriasis: Principles, Present, and Near Future | Dermatology and Therapy | 2018 |