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 |