164
Citations
76
Journals
2015
First Cited
2022
Last Cited

Articles citing This Document (Page 2 of 4)

ArticleJournalYear
Systematic Review on the Use of Biosimilars of Trastuzumab in HER2+ Breast Cancer2022
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 Biosimilars2022
Statistical Aspects of Bioanalytical Testing2022
No two classes of biosimilars: Urgent advice to the US Congress and the FDAJournal of Clinical Pharmacy and Therapeutics
DataSheet_1.docx2020
table_2.PDF2018
table_1.PDF2018
image_2.PDF2018
image_1.PDF2018
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.BioDrugs2022
Long-term data on the proposed adalimumab biosimilar BCD-057 in patients with moderate to severe psoriasis: A randomized controlled trial.PLoS ONE2022
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
Biosimilars2018
Application of an Adaptive Analytical Characterization Strategy to Support Development and Approval of BiosimilarsAAPS Advances in the Pharmaceutical Sciences Series2018
Switching between reference adalimumab and biosimilars in chronic immune-mediated inflammatory diseases: A systematic literature reviewBritish Journal of Clinical Pharmacology2021
BIOSIMILARS IN RHEUMATOLOGYNauchno-Prakticheskaya Revmatologiya2017
Policies for biosimilar uptake in Europe: An overviewPLoS ONE2017
Arzneimittelverordnungen nach Regionen2017
Arzneiverordnungen 2016 im Überblick2017
Pharmacovigilance of Biosimilars: Global Experience and PerspectiveAAPS Advances in the Pharmaceutical Sciences Series2018
The Expiry of Humira Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy MeasuresFrontiers in Pharmacology2020
A Randomized, Double-Blind, Single-Dose Study Comparing the Biosimilarity of HOT-1010 With Bevacizumab (Avastin®) in Chinese Healthy Male SubjectsFrontiers in Pharmacology2021
Cost evolution of biological drugs in rheumatoid arthritis patients in a tertiary hospital: Influential factors on priceReumatología Clínica (English Edition)2021
Cost evolution of biological drugs in rheumatoid arthritis patients in a tertiary hospital: Influential factors on priceReumatología Clínica2021
Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab BiosimilarBioDrugs2021
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 trialDiabetes, Obesity and Metabolism2021
A Biosimilarity Study Between QX001S and Ustekinumab in Healthy Chinese Male SubjectsFrontiers in Pharmacology2021
Evolving Biosimilar Clinical Requirements: A Qualitative Interview Study with Industry Experts and European National Medicines Agency RegulatorsBioDrugs2021
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
Safety and pharmacokinetics of a biosimilar of denosumab (KN012): Phase 1 and bioequivalence study in healthy Chinese subjectsExpert Opinion on Investigational Drugs2021
Efficacy and safety of follitropin alpha biosimilars compared to their reference product: a Meta-analysisGynecological Endocrinology2021
Economic evaluation of biosimilars for reimbursement purposes - what, when, how?Journal of Market Access & Health Policy2020
A randomized phase I pharmacokinetic trial comparing the potential biosimilar adalimumab (CinnoRA®) with the reference product (Humira®) in healthy volunteersExpert Opinion on Investigational Drugs2020
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
Biosimilar Drug Development2020
Higher-Order Structure Comparison of a Proposed Biosimilar and the Innovator Biotherapeutic Trastuzumab using Circular Dichroism Coupled with Statistical AnalysisJournal of Applied Spectroscopy2020
Potential Cost-Savings From the Use of the Biosimilars in SlovakiaFrontiers in Public Health2020
A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy SubjectsFrontiers in Pharmacology2020
The Importance of Countering Biosimilar Disparagement and MisinformationBioDrugs2020
Tendering and biosimilars: what role for value-added services?Journal of Market Access & Health Policy2020
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
A randomized, double-blind, single-dose study to evaluate the biosimilarity of QL1101 with bevacizumab in healthy male subjectsCancer Chemotherapy and Pharmacology2020
Etanercept biosimilar SB-4Expert Opinion on Biological Therapy2019
PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind studyBritish Journal of Cancer2019
Regulation of biosimilar medicines and current perspectives on interchangeability and policyEuropean Journal of Clinical Pharmacology2019
Similarity assessment of quality attributes of biological medicines: the calculation of operating characteristics to compare different statistical approachesAAPS Open2019
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 studyArthritis Research and Therapy2019
Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU- Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?BioDrugs2019
A Review of the Totality of Evidence Supporting the Development of the First Adalimumab Biosimilar ABP 501Advances in Therapy2019
Cost-Effectiveness of Early Treatment with Originator Biologics or Their Biosimilars After Methotrexate Failure in Patients with Established Rheumatoid ArthritisAdvances in Therapy2019
Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American surveyPharmacoepidemiology and Drug Safety2019
Biosimilars: A Value PropositionBioDrugs2019
Biological Characterization of SB3, a Trastuzumab Biosimilar, and the Influence of Changes in Reference Product Characteristics on the Similarity AssessmentBioDrugs2019
Readability assessment of package leaflets of biosimilarsBMJ Open2019
Extrapolation in Practice: Lessons from 10 Years with Biosimilar FilgrastimBioDrugs2019
Biosimilar and interchangeable: Inseparable scientific concepts?British Journal of Clinical Pharmacology2019
Population pharmacokinetics of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderately to severely active rheumatoid arthritisExpert Opinion on Biological Therapy2019
A phase III study of BCD-055 compared with innovator infliximab in patients with active rheumatoid arthritis: 54-week results from the LIRA studyRheumatology International2019
An Efficient Development Paradigm for BiosimilarsBioDrugs2019
CT-P13: a review on a biosimilar to infliximab in the treatment of inflammatory bowel diseaseExpert Opinion on Biological Therapy2019
[Knowledge about Biosimilars in Primary Care: a study by the Spanish Society of Primary Care Physicians (SEMERGEN)]Semergen2018
EU pharmacovigilance regulatory requirements of anticancer biosimilar monoclonal antibodiesInternational Journal of Clinical Pharmacy2018
Neoadjuvant PF-05280014 (a potential trastuzumab biosimilar) versus trastuzumab for operable HER2+ breast cancerBritish Journal of Cancer2018
A proposal for a new PhD level curriculum on quantitative methods for drug developmentPharmaceutical Statistics2018
Tolerance, variability, and pharmacokinetics of bevacizumab biosimilars in Chinese healthy male subjectsCancer Chemotherapy and Pharmacology2018
Comparative Safety of Originator and Biosimilar Epoetin Alfa Drugs: An Observational Prospective Multicenter StudyBioDrugs2018
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 therapyArthritis Research and Therapy2018
A comparative pharmacokinetic study of DRL_BZ, a candidate biosimilar of bevacizumab, with Avastin (EU and US) in healthy male subjectsBritish Journal of Clinical Pharmacology2018
Global Acceptance of Biosimilars: Importance of Regulatory Consistency, Education, and TrustOncologist2018
Concepts and Challenges of Biosimilars in Breast Cancer: The Emergence of Trastuzumab BiosimilarsPharmaceutics2018
Systematic Review and Meta-analysis of Short- versus Long-Acting Granulocyte Colony-Stimulating Factors for Reduction of Chemotherapy-Induced Febrile NeutropeniaAdvances in Therapy2018
An evaluation roadmap for critical quality attributes from tier 1 in analytical similarity assessmentPLoS ONE2018
Totality of Evidence and the Role of Clinical Studies in Establishing BiosimilarityAAPS Advances in the Pharmaceutical Sciences Series2018
Comparing safety information of biosimilars with their originators: a cross-sectional analysis of European risk management plansBritish Journal of Clinical Pharmacology2018
Clinical equivalence with G-CSF biosimilars: methodologic approach in a (neo)adjuvant setting in non-metastatic breast cancerSupportive Care in Cancer2018
Consensus-based recommendations for the use of biosimilars to treat rheumatological diseasesAnnals of the Rheumatic Diseases2018
Variability of intended copies for etanercept (Enbrel®): Data on multiple batches of seven productsMAbs2018
Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human UseAAPS PharmSciTech2018
Progress in biopharmaceutical developmentBiotechnology and Applied Biochemistry2018
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 studyAnnals of the Rheumatic Diseases2018
Comprehensive Physicochemical and Biological Characterization of the Proposed Biosimilar Darbepoetin Alfa, LBDE, and Its Originator Darbepoetin Alfa, NESPBioDrugs2018
Biosimilar Drugs for Psoriasis: Principles, Present, and Near FutureDermatology and Therapy2018
Monoclonal Antibody Biosimilars in Oncology: Critical Appraisal of Available Data on SwitchingClinical Therapeutics2018
Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in IrelandBioDrugs2018
Maintaining consistent quality and clinical performance of biopharmaceuticalsExpert Opinion on Biological Therapy2018
Biosimilars in Dermatology2018
Safety Profile of Biosimilar Filgrastim (Zarzio/Zarxio): A Combined Analysis of Phase III StudiesOncologist2018
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 methotrexateAnnals of the Rheumatic Diseases2018
Biosimilars: what the dermatologist should knowJournal of the European Academy of Dermatology and Venereology2018
Comparative assessment of pharmacokinetics, and pharmacodynamics between RTXM83™, a rituximab biosimilar, and rituximab in diffuse large B-cell lymphoma patients: a population PK model approachCancer Chemotherapy and Pharmacology2018
Biosimilars in oncology: much ado about nothing?Annals of Oncology2018
Biosimilars2018
Biosimilars in rheumatology: recommendations for regulation and use in Middle Eastern countriesClinical Rheumatology2018
The Science Behind Biosimilars: Entering a New Era of Biologic TherapyArthritis and Rheumatology2018