| 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? | | |
| Under the Umbrella of Clinical Pharmacology: Inflammatory Bowel Disease, Infliximab and Adalimumab, and a Bridge to an Era of Biosimilars | | 2022 |
| Statistical Aspects of Bioanalytical Testing | | 2022 |
| No two classes of biosimilars: Urgent advice to the US Congress and the FDA | Journal of Clinical Pharmacy and Therapeutics | |
| DataSheet_1.docx | | 2020 |
| table_2.PDF | | 2018 |
| table_1.PDF | | 2018 |
| image_2.PDF | | 2018 |
| image_1.PDF | | 2018 |
| Long-Term Safety and Effectiveness of PF-05280014 (a Trastuzumab Biosimilar) Treatment in Patients with HER2-Positive Metastatic Breast Cancer: Updated Results of a Randomized, Double-Blind Study. | BioDrugs | 2022 |
| Long-term data on the proposed adalimumab biosimilar BCD-057 in patients with moderate to severe psoriasis: A randomized controlled trial. | PLoS ONE | 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 | | 2018 |
| Application of an Adaptive Analytical Characterization Strategy to Support Development and Approval of Biosimilars | AAPS Advances in the Pharmaceutical Sciences Series | 2018 |
| Switching between reference adalimumab and biosimilars in chronic immune-mediated inflammatory diseases: A systematic literature review | British Journal of Clinical Pharmacology | 2021 |
| BIOSIMILARS IN RHEUMATOLOGY | Nauchno-Prakticheskaya Revmatologiya | 2017 |
| Policies for biosimilar uptake in Europe: An overview | PLoS ONE | 2017 |
| Arzneimittelverordnungen nach Regionen | | 2017 |
| Arzneiverordnungen 2016 im Überblick | | 2017 |
| Pharmacovigilance of Biosimilars: Global Experience and Perspective | AAPS Advances in the Pharmaceutical Sciences Series | 2018 |
| The Expiry of Humira Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures | Frontiers in Pharmacology | 2020 |
| 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 |
| Cost evolution of biological drugs in rheumatoid arthritis patients in a tertiary hospital: Influential factors on price | Reumatología Clínica (English Edition) | 2021 |
| Cost evolution of biological drugs in rheumatoid arthritis patients in a tertiary hospital: Influential factors on price | Reumatología Clínica | 2021 |
| Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar | BioDrugs | 2021 |
| Efficacy and safety of LY2963016 insulin glargine versus insulin glargine (Lantus) in Chinese adults with type 2 diabetes: A phase III, randomized, open-label, controlled trial | Diabetes, Obesity and Metabolism | 2021 |
| A Biosimilarity Study Between QX001S and Ustekinumab in Healthy Chinese Male Subjects | Frontiers in Pharmacology | 2021 |
| Evolving Biosimilar Clinical Requirements: A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators | 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 |
| Safety and pharmacokinetics of a biosimilar of denosumab (KN012): Phase 1 and bioequivalence study in healthy Chinese subjects | Expert Opinion on Investigational Drugs | 2021 |
| Efficacy and safety of follitropin alpha biosimilars compared to their reference product: a Meta-analysis | Gynecological Endocrinology | 2021 |
| Economic evaluation of biosimilars for reimbursement purposes - what, when, how? | Journal of Market Access & Health Policy | 2020 |
| A randomized phase I pharmacokinetic trial comparing the potential biosimilar adalimumab (CinnoRA®) with the reference product (Humira®) in healthy volunteers | Expert Opinion on Investigational Drugs | 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 |
| Biosimilar Drug Development | | 2020 |
| Higher-Order Structure Comparison of a Proposed Biosimilar and the Innovator Biotherapeutic Trastuzumab using Circular Dichroism Coupled with Statistical Analysis | Journal of Applied Spectroscopy | 2020 |
| Potential Cost-Savings From the Use of the Biosimilars in Slovakia | Frontiers in Public Health | 2020 |
| A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy Subjects | Frontiers in Pharmacology | 2020 |
| The Importance of Countering Biosimilar Disparagement and Misinformation | BioDrugs | 2020 |
| Tendering and biosimilars: what role for value-added services? | Journal of Market Access & Health Policy | 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 |
| A randomized, double-blind, single-dose study to evaluate the biosimilarity of QL1101 with bevacizumab in healthy male subjects | Cancer Chemotherapy and Pharmacology | 2020 |
| Etanercept biosimilar SB-4 | Expert Opinion on Biological Therapy | 2019 |
| PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study | British Journal of Cancer | 2019 |
| Regulation of biosimilar medicines and current perspectives on interchangeability and policy | European Journal of Clinical Pharmacology | 2019 |
| Similarity assessment of quality attributes of biological medicines: the calculation of operating characteristics to compare different statistical approaches | AAPS Open | 2019 |
| Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: an open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study | Arthritis Research and Therapy | 2019 |
| Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU- Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development? | BioDrugs | 2019 |
| A Review of the Totality of Evidence Supporting the Development of the First Adalimumab Biosimilar ABP 501 | Advances in Therapy | 2019 |
| Cost-Effectiveness of Early Treatment with Originator Biologics or Their Biosimilars After Methotrexate Failure in Patients with Established Rheumatoid Arthritis | Advances in Therapy | 2019 |
| Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey | Pharmacoepidemiology and Drug Safety | 2019 |
| Biosimilars: A Value Proposition | BioDrugs | 2019 |
| Biological Characterization of SB3, a Trastuzumab Biosimilar, and the Influence of Changes in Reference Product Characteristics on the Similarity Assessment | BioDrugs | 2019 |
| Readability assessment of package leaflets of biosimilars | BMJ Open | 2019 |
| Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim | BioDrugs | 2019 |
| Biosimilar and interchangeable: Inseparable scientific concepts? | British Journal of Clinical Pharmacology | 2019 |
| Population pharmacokinetics of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderately to severely active rheumatoid arthritis | Expert Opinion on Biological Therapy | 2019 |
| A phase III study of BCD-055 compared with innovator infliximab in patients with active rheumatoid arthritis: 54-week results from the LIRA study | Rheumatology International | 2019 |
| An Efficient Development Paradigm for Biosimilars | BioDrugs | 2019 |
| CT-P13: a review on a biosimilar to infliximab in the treatment of inflammatory bowel disease | Expert Opinion on Biological Therapy | 2019 |
| [Knowledge about Biosimilars in Primary Care: a study by the Spanish Society of Primary Care Physicians (SEMERGEN)] | Semergen | 2018 |
| EU pharmacovigilance regulatory requirements of anticancer biosimilar monoclonal antibodies | International Journal of Clinical Pharmacy | 2018 |
| Neoadjuvant PF-05280014 (a potential trastuzumab biosimilar) versus trastuzumab for operable HER2+ breast cancer | British Journal of Cancer | 2018 |
| A proposal for a new PhD level curriculum on quantitative methods for drug development | Pharmaceutical Statistics | 2018 |
| Tolerance, variability, and pharmacokinetics of bevacizumab biosimilars in Chinese healthy male subjects | Cancer Chemotherapy and Pharmacology | 2018 |
| Comparative Safety of Originator and Biosimilar Epoetin Alfa Drugs: An Observational Prospective Multicenter Study | BioDrugs | 2018 |
| A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy | Arthritis Research and Therapy | 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 |
| Concepts and Challenges of Biosimilars in Breast Cancer: The Emergence of Trastuzumab Biosimilars | Pharmaceutics | 2018 |
| Systematic Review and Meta-analysis of Short- versus Long-Acting Granulocyte Colony-Stimulating Factors for Reduction of Chemotherapy-Induced Febrile Neutropenia | Advances in Therapy | 2018 |
| An evaluation roadmap for critical quality attributes from tier 1 in analytical similarity assessment | PLoS ONE | 2018 |
| Totality of Evidence and the Role of Clinical Studies in Establishing Biosimilarity | AAPS Advances in the Pharmaceutical Sciences Series | 2018 |
| Comparing safety information of biosimilars with their originators: a cross-sectional analysis of European risk management plans | British Journal of Clinical Pharmacology | 2018 |
| Clinical equivalence with G-CSF biosimilars: methodologic approach in a (neo)adjuvant setting in non-metastatic breast cancer | Supportive Care in Cancer | 2018 |
| Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases | Annals of the Rheumatic Diseases | 2018 |
| Variability of intended copies for etanercept (Enbrel®): Data on multiple batches of seven products | MAbs | 2018 |
| Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use | AAPS PharmSciTech | 2018 |
| Progress in biopharmaceutical development | Biotechnology and Applied Biochemistry | 2018 |
| Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study | Annals of the Rheumatic Diseases | 2018 |
| Comprehensive Physicochemical and Biological Characterization of the Proposed Biosimilar Darbepoetin Alfa, LBDE, and Its Originator Darbepoetin Alfa, NESP | BioDrugs | 2018 |
| Biosimilar Drugs for Psoriasis: Principles, Present, and Near Future | Dermatology and Therapy | 2018 |
| Monoclonal Antibody Biosimilars in Oncology: Critical Appraisal of Available Data on Switching | Clinical Therapeutics | 2018 |
| Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in Ireland | BioDrugs | 2018 |
| Maintaining consistent quality and clinical performance of biopharmaceuticals | Expert Opinion on Biological Therapy | 2018 |
| Biosimilars in Dermatology | | 2018 |
| Safety Profile of Biosimilar Filgrastim (Zarzio/Zarxio): A Combined Analysis of Phase III Studies | Oncologist | 2018 |
| Phase III, multicentre, double-blind, randomised, parallel-group study to evaluate the similarities between LBEC0101 and etanercept reference product in terms of efficacy and safety in patients with active rheumatoid arthritis inadequately responding to methotrexate | Annals of the Rheumatic Diseases | 2018 |
| Biosimilars: what the dermatologist should know | Journal of the European Academy of Dermatology and Venereology | 2018 |
| Comparative assessment of pharmacokinetics, and pharmacodynamics between RTXM83™, a rituximab biosimilar, and rituximab in diffuse large B-cell lymphoma patients: a population PK model approach | Cancer Chemotherapy and Pharmacology | 2018 |
| Biosimilars in oncology: much ado about nothing? | Annals of Oncology | 2018 |
| Biosimilars | | 2018 |
| Biosimilars in rheumatology: recommendations for regulation and use in Middle Eastern countries | Clinical Rheumatology | 2018 |
| The Science Behind Biosimilars: Entering a New Era of Biologic Therapy | Arthritis and Rheumatology | 2018 |
| [Revised version of the statement by the DGRh on biosimilars-update 2017] | Zeitschrift Fur Rheumatologie | 2018 |
| The nocebo effect challenges the non-medical infliximab switch in practice | European Journal of Clinical Pharmacology | 2018 |
| Immunogenicity Assessment of Biosimilars | Pharmaceutical Medicine | 2018 |
| An update on the clinical evidence that supports biosimilar approvals in Europe | British Journal of Clinical Pharmacology | 2018 |
| Epoetin Biosimilars in the Treatment of Renal Anemia: What Have We Learned from a Decade of European Experience? | Clinical Drug Investigation | 2018 |
| Biosimilars in the Treatment of Inflammatory Bowel Disease: Supporting Evidence in 2017 | Current Treatment Options in Gastroenterology | 2018 |
| Barriers to the Access of Bevacizumab in Patients with Solid Tumors and the Potential Impact of Biosimilars: A Physician Survey | Pharmaceuticals | 2017 |
| The ESMO position paper on biosimilars in oncology: enhancing the provision of accurate education and information | ESMO Open | 2017 |
| Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: a 6-month real-life observational study | Immunologic Research | 2017 |
| Biosimilars in IBD: from theory to practice | Nature Reviews Gastroenterology and Hepatology | 2017 |
| The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis | British Journal of Dermatology | 2017 |
| Assessing the Value of Biosimilars: A Review of the Role of Budget Impact Analysis | Pharmacoeconomics | 2017 |
| Equivalence and regulatory approaches of nonbiological complex drug products across the United States, the European Union, and Turkey | Annals of the New York Academy of Sciences | 2017 |
| Bevacizumab in Colorectal Cancer: Current Role in Treatment and the Potential of Biosimilars | Targeted Oncology | 2017 |
| Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis | British Journal of Dermatology | 2017 |
| Update on Biosimilars in Asia | Current Rheumatology Reports | 2017 |
| A randomized phase I comparative pharmacokinetic study comparing SB5 with reference adalimumab in healthy volunteers | Journal of Clinical Pharmacy and Therapeutics | 2017 |
| Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study | Journal of the American Academy of Dermatology | 2017 |
| Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study | Annals of the Rheumatic Diseases | 2017 |
| Biosimilar biologic drugs: a new frontier in medical care | Postgraduate Medicine | 2017 |
| Introduction of biosimilar insulins in Europe | Diabetic Medicine | 2017 |
| Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis | BioDrugs | 2017 |
| Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study | Annals of the Rheumatic Diseases | 2017 |
| Clinical trials of biosimilars should become more similar | Annals of the Rheumatic Diseases | 2017 |
| Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician | Current Rheumatology Reports | 2017 |
| Clinical Trial Design in Juvenile Idiopathic Arthritis | Paediatric Drugs | 2017 |
| Biosimilars in the Treatment of Inflammatory Bowel Disease | | 2017 |
| Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community | BioDrugs | 2017 |
| Current Status of Biosimilars in Oncology | Drugs | 2017 |
| The introduction of biosimilars of low molecular weight heparins in Europe: a critical review and reappraisal endorsed by the Italian Society for Haemostasis and Thrombosis (SISET) and the Italian Society for Angiology and Vascular Medicine (SIAPAV) | Thrombosis Journal | 2017 |
| Comparing Originator Biologics and Biosimilars: A Review of the Relevant Issues | Clinical Therapeutics | 2017 |
| Manufacturing of Recombinant Human Follicle-Stimulating Hormone Ovaleap (XM17), Comparability with Gonal-f, and Performance/Consistency | Drugs in R and D | 2017 |
| The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects | Drugs | 2017 |
| Biosimilar infliximab for the management of rheumatoid arthritis in France: what are the expected savings? | European Journal of Hospital Pharmacy | 2017 |
| Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study | Annals of the Rheumatic Diseases | 2017 |
| Interchangeability of Biosimilars: A European Perspective | BioDrugs | 2017 |
| Long-term safety and efficacy of Omnitrope in adults with growth hormone deficiency: Italian interim analysis of the PATRO Adults study | Journal of Endocrinological Investigation | 2017 |
| The totality-of-the-evidence approach to the development and assessment of GP2015, a proposed etanercept biosimilar | Current Medical Research and Opinion | 2017 |
| Biosimilars in rheumatology: understanding the rigor of their development | Rheumatology | 2017 |
| A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy | Annals of the Rheumatic Diseases | 2017 |
| A phase I pharmacokinetics study comparing PF-06439535 (a potential biosimilar) with bevacizumab in healthy male volunteers | Cancer Chemotherapy and Pharmacology | 2016 |
| Biosimilars in Inflammatory Bowel Disease: Facts and Fears of Extrapolation | Clinical Gastroenterology and Hepatology | 2016 |
| The opportunities and challenges of biosimilar orphans | Expert Opinion on Orphan Drugs | 2016 |
| Biosimilar Oncology Drugs in Europe: Regulatory and Pharmacovigilance Considerations | Oncology and Therapy | 2016 |
| Rheumatologists' Perceptions of Biosimilar Medicines Prescription: Findings from a French Web-Based Survey | BioDrugs | 2016 |
| Demonstration of Functional Similarity of Proposed Biosimilar ABP 501 to Adalimumab | BioDrugs | 2016 |
| Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP 501 to Adalimumab | BioDrugs | 2016 |
| [Are the most recent basal insulins really the most innovative?] | Medicina Clínica | 2016 |
| Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study | Arthritis Research and Therapy | 2016 |
| How did the Introduction of Biosimilar Filgrastim Influence the Prescribing Pattern of Granulocyte Colony-Stimulating Factors? Results from a Multicentre, Population-Based Study, from Five Italian Centres in the Years 2009-2014 | BioDrugs | 2016 |
