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1. Full Text Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2 (HER2)–Positive Metastatic Breast Cancer: A Randomized Clinical Trial
by Rugo, Hope S and Barve, Abhijit and Waller, Cornelius F and Hernandez-Bronchud, Miguel and Herson, Jay and Yuan, Jinyu and Sharma, Rajiv and Baczkowski, Mark and Kothekar, Mudgal and Loganathan, Subramanian and Manikhas, Alexey and Bondarenko, Igor and Mukhametshina, Guzel and Nemsadze, Gia and Parra, Joseph D and Abesamis-Tiambeng, Maria Luisa T and Baramidze, Kakhaber and Akewanlop, Charuwan and Vynnychenko, Ihor and Sriuranpong, Virote and Mamillapalli, Gopichand and Ray, Sirshendu and Yanez Ruiz, Eduardo P and Pennella, Eduardo and Heritage Study Investigators and for the Heritage Study Investigators
JAMA : the journal of the American Medical Association, ISSN 0098-7484, 01/2017, Volume 317, Issue 1, pp. 37 - 47
Medicine, General & Internal | Life Sciences & Biomedicine | General & Internal Medicine | Science & Technology | Humans | Middle Aged | Antineoplastic Combined Chemotherapy Protocols - adverse effects | Antineoplastic Agents - therapeutic use | Taxoids - therapeutic use | Breast Neoplasms - chemistry | Time Factors | Antineoplastic Agents - adverse effects | Aged, 80 and over | Adult | Female | Antineoplastic Agents, Phytogenic - therapeutic use | Taxoids - adverse effects | Antineoplastic Agents, Phytogenic - adverse effects | Biosimilar Pharmaceuticals - therapeutic use | Trastuzumab - therapeutic use | Double-Blind Method | Antineoplastic Agents - immunology | Paclitaxel - adverse effects | Trastuzumab - adverse effects | Breast Neoplasms - drug therapy | Paclitaxel - therapeutic use | Remission Induction | Disease Progression | Biosimilar Pharmaceuticals - adverse effects | Antineoplastic Combined Chemotherapy Protocols - therapeutic use | Breast Neoplasms - pathology | Intention to Treat Analysis | Survival Analysis | Breast Neoplasms - mortality | Aged | Receptor, ErbB-2 | Therapeutic Equipoise | Trastuzumab - immunology | Outcome and process assessment (Health Care) | Care and treatment | Breast cancer | Health aspects | Analysis | Young women | Patient safety | Oncology | Biological products | Biomedical research | Womens health | Index Medicus | Abridged Index Medicus
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2. Interchangeability of Biosimilars: A European Perspective
by Kurki, Pekka and van Aerts, Leon and Wolff-Holz, Elena and Giezen, Thijs and Skibeli, Venke and Weise, Martina
BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy, ISSN 1173-8804, 04/2017, Volume 31, Issue 2, pp. 83 - 91
Pharmacology & Pharmacy | Oncology | Immunology | Life Sciences & Biomedicine | Science & Technology | Etanercept - adverse effects | Filgrastim - adverse effects | Epoetin Alfa - adverse effects | Humans | Antibodies, Monoclonal - adverse effects | Human Growth Hormone - adverse effects | Adalimumab - adverse effects | Biosimilar Pharmaceuticals - adverse effects | Adalimumab - therapeutic use | Drug Industry - methods | European Union | Immune System - drug effects | Biosimilar Pharmaceuticals - pharmacokinetics | Etanercept - therapeutic use | Competition | Biotechnology | Biological products | Legislation | Switches | Arthritis | Patients | Insulin | Switching | Proteins | Medicine | Immunogenicity | Gastroenterology | Manufacturing | Product safety | Drug stores
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3. Full Text Biosimilars: What clinicians should know
by Weise, Martina and Bielsky, Marie-Christine and De Smet, Karen and Ehmann, Falk and Ekman, Niklas and Giezen, Thijs J and Gravanis, Iordanis and Heim, Hans-Karl and Heinonen, Esa and Ho, Kowid and Moreau, Alexandre and Narayanan, Gopalan and Kruse, Nanna A and Reichmann, Gabriele and Thorpe, Robin and Van Aerts, Leon and Vleminckx, Camille and Wadhwa, Meenu and Schneider, Christian K
Blood, ISSN 0006-4971, 12/2012, Volume 120, Issue 26, pp. 5111 - 5117
Life Sciences & Biomedicine | Hematology | Science & Technology | Hematologic and hematopoietic diseases | Biological and medical sciences | Medical sciences | Education, Medical, Continuing | Professional Practice - trends | Biosimilar Pharmaceuticals - therapeutic use | Biosimilar Pharmaceuticals - administration & dosage | Physicians | Humans | Drug-Related Side Effects and Adverse Reactions - etiology | Biosimilar Pharmaceuticals - pharmacology | Health Knowledge, Attitudes, Practice | Biosimilar Pharmaceuticals - adverse effects | Drug-Related Side Effects and Adverse Reactions - epidemiology | Index Medicus | Abridged Index Medicus
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4. Full Text Phase III, randomized, double-blind study comparing the efficacy, safety, and immunogenicity of SB3 (trastuzumab biosimilar) and reference trastuzumab in patients treated with neoadjuvant therapy for human epidermal growth factor receptor 2-positive early breast cancer
by Pivot, Xavier and Bondarenko, Igor and Nowecki, Zbigniew and Dvorkin, Mikhail and Trishkina, Ekaterina and Ahn, Jin-Hee and Vinnyk, Yuriy and Im, Seock-Ah and Sarosiek, Tomasz and Chatterjee, Sanjoy and Wojtukiewicz, Marek Z and Moiseyenko, Vladimir and Shparyk, Yaroslav and Bello, Maximino and Semiglazov, Vladimir and Song, Sujeong and Lim, Jaeyun
Journal of clinical oncology, ISSN 0732-183X, 04/2018, Volume 36, Issue 10, pp. 968 - 974
Life Sciences & Biomedicine | Oncology | Science & Technology | Breast Neoplasms - surgery | Cyclophosphamide - administration & dosage | Docetaxel - adverse effects | Humans | Middle Aged | Antineoplastic Combined Chemotherapy Protocols - adverse effects | Epirubicin - administration & dosage | Cyclophosphamide - adverse effects | Young Adult | Breast Neoplasms - enzymology | Docetaxel - administration & dosage | Fluorouracil - administration & dosage | Fluorouracil - adverse effects | Adult | Female | Neoadjuvant Therapy | Chemotherapy, Adjuvant | Receptor, ErbB-2 - biosynthesis | Biosimilar Pharmaceuticals - administration & dosage | Double-Blind Method | Trastuzumab - adverse effects | Trastuzumab - administration & dosage | Breast Neoplasms - drug therapy | Biosimilar Pharmaceuticals - adverse effects | Antineoplastic Combined Chemotherapy Protocols - therapeutic use | Breast Neoplasms - pathology | Aged | Epirubicin - adverse effects
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5. Full Text A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy
by Emery, Paul and Vencovský, Jiří and Sylwestrzak, Anna and Leszczyński, Piotr and Porawska, Wieslawa and Baranauskaite, Asta and Tseluyko, Vira and Zhdan, Vyacheslav M and Stasiuk, Barbara and Milasiene, Roma and Barrera Rodriguez, Aaron Alejandro and Cheong, Soo Yeon and Ghil, Jeehoon
Annals of the rheumatic diseases, ISSN 0003-4967, 01/2017, Volume 76, Issue 1, pp. 51 - 57
Life Sciences & Biomedicine | Rheumatology | Science & Technology | Biosimilar Pharmaceuticals - therapeutic use | Etanercept - adverse effects | Double-Blind Method | Humans | Middle Aged | Antirheumatic Agents - immunology | Male | Treatment Outcome | Methotrexate - therapeutic use | Biosimilar Pharmaceuticals - adverse effects | Arthritis, Rheumatoid - drug therapy | Etanercept - pharmacokinetics | Etanercept - immunology | Antirheumatic Agents - adverse effects | Biosimilar Pharmaceuticals - pharmacokinetics | Adult | Antibodies - blood | Antirheumatic Agents - pharmacokinetics | Female | Aged | Antirheumatic Agents - therapeutic use | Etanercept - therapeutic use | Therapeutic Equivalency | Treatment outcome | Usage | Care and treatment | Safety and security measures | Etanercept | Rheumatoid arthritis | Analysis | Dosage and administration | Methotrexate | Index Medicus | Anti-TNF | DMARDs (biologic) | Clinical and Epidemiological Research | Rheumatoid Arthritis | 1507 | 1506
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6. Full Text Long-Term Clinical Outcomes After Switching from Remicade((R)) to Biosimilar CT-P13 in Inflammatory Bowel Disease
by Smits, L.J.T and Grelack, A and Derikx, L.A.A.P and Jong, D.J. de and Esch, A.A.J. van and Boshuizen, R.S and nth, J.P.H and Hoentjen, F
Digestive diseases and sciences, ISSN 0163-2116, 2017, Volume 62, Issue 11, pp. 3117 - 3122
Biochemistry, general | Inflammatory bowel diseases | Disease activity | Medicine & Public Health | Infliximab | Switch | Immunogenicity | Hepatology | Gastroenterology | Biosimilar pharmaceuticals | Oncology | Transplant Surgery | Gastroenterology & Hepatology | Life Sciences & Biomedicine | Science & Technology | Prospective Studies | Humans | Middle Aged | Antibodies, Monoclonal - adverse effects | Gastrointestinal Agents - administration & dosage | Male | Colitis, Ulcerative - immunology | Infliximab - administration & dosage | Feasibility Studies | Young Adult | Infliximab - adverse effects | Netherlands | Crohn Disease - diagnosis | Tumor Necrosis Factor-alpha - immunology | Biosimilar Pharmaceuticals - pharmacokinetics | Adult | Female | Colitis, Ulcerative - drug therapy | Gastrointestinal Agents - pharmacokinetics | Biosimilar Pharmaceuticals - administration & dosage | Antibodies, Monoclonal - pharmacokinetics | Treatment Outcome | Crohn Disease - immunology | Biosimilar Pharmaceuticals - adverse effects | Colitis, Ulcerative - diagnosis | Antibodies, Monoclonal - administration & dosage | Crohn Disease - drug therapy | Adolescent | Aged | Gastrointestinal Agents - adverse effects | Drug Substitution | Tumor Necrosis Factor-alpha - antagonists & inhibitors | Therapeutic Equivalency | Index Medicus | Abridged Index Medicus | Original
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7. Full Text Non-pharmacological Effects in Switching Medication: The Nocebo Effect in Switching from Originator to Biosimilar Agent
by Kristensen, Lars Erik and Alten, Rieke and Puig, Luis and Philipp, Sandra and Kvien, Tore K and Mangues, Maria Antonia and van den Hoogen, Frank and Pavelka, Karel and Vulto, Arnold G
BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy, ISSN 1173-8804, 10/2018, Volume 32, Issue 5, pp. 397 - 404
Antibodies | Pharmacotherapy | Cancer Research | Molecular Medicine | Biomedicine | Pharmacology & Pharmacy | Oncology | Immunology | Life Sciences & Biomedicine | Science & Technology | Biosimilar Pharmaceuticals - therapeutic use | Nocebo Effect | Patient Medication Knowledge | Humans | Physician-Patient Relations | Treatment Outcome | Biosimilar Pharmaceuticals - adverse effects
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8. Biosimilar monoclonal antibodies: Preclinical and clinical development aspects
by Gonçalves, João and Araújo, Filipe and Cutolo, Maurizio and Fonseca, João Eurico
Clinical and Experimental Rheumatology, ISSN 0392-856X, 2016, Volume 34, Issue 4, pp. 698 - 705
Inflammatory bowel disease | Anti-rheumatic agents | Rheumatoid arthritis | Biosimilar pharmaceuticals | CT-P13 | Therapeutic equivalence | Ankylosing spondylitis | Life Sciences & Biomedicine | Rheumatology | Science & Technology | Rheumatic Diseases - drug therapy | Humans | Inflammatory Bowel Diseases - immunology | Antibodies, Monoclonal - adverse effects | Inflammatory Bowel Diseases - diagnosis | Antibodies, Monoclonal - therapeutic use | Drugs, Generic - therapeutic use | Anti-Inflammatory Agents - adverse effects | Patient Safety | Anti-Inflammatory Agents - therapeutic use | Antirheumatic Agents - adverse effects | Biosimilar Pharmaceuticals - pharmacokinetics | Anti-Inflammatory Agents - pharmacokinetics | Drug Evaluation, Preclinical | Gastrointestinal Agents - pharmacokinetics | Gastrointestinal Agents - standards | Drugs, Generic - standards | Antirheumatic Agents - therapeutic use | Quality Control | Rheumatic Diseases - immunology | Inflammatory Bowel Diseases - drug therapy | Biosimilar Pharmaceuticals - therapeutic use | Risk Assessment | Antirheumatic Agents - standards | Biosimilar Pharmaceuticals - standards | Antibodies, Monoclonal - pharmacokinetics | Treatment Outcome | Clinical Trials as Topic | Rheumatic Diseases - diagnosis | Patents as Topic | Anti-Inflammatory Agents - standards | Biosimilar Pharmaceuticals - adverse effects | Drugs, Generic - adverse effects | Animals | Drug Approval - methods | Gastrointestinal Agents - therapeutic use | Antirheumatic Agents - pharmacokinetics | Gastrointestinal Agents - adverse effects | Therapeutic Equivalency
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9. Full Text 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
by Choe, Jung-Yoon and Prodanovic, Nenad and Niebrzydowski, Jaroslaw and Staykov, Ivan and Dokoupilova, Eva and Baranauskaite, Asta and Yatsyshyn, Roman and Mekic, Mevludin and Porawska, Wieskawa and Ciferska, Hana and Jedrychowicz-Rosiak, Krystyna and Zielinska, Agnieszka and Choi, Jasmine and Rho, Young Hee and Smolen, Josef S
Annals of the rheumatic diseases, ISSN 0003-4967, 01/2017, Volume 76, Issue 1, pp. 58 - 64
Life Sciences & Biomedicine | Rheumatology | Science & Technology | Severity of Illness Index | Biosimilar Pharmaceuticals - therapeutic use | Double-Blind Method | Humans | Middle Aged | Male | Treatment Outcome | Methotrexate - therapeutic use | Infliximab - immunology | Infliximab - therapeutic use | Infliximab - pharmacokinetics | Biosimilar Pharmaceuticals - adverse effects | Infliximab - adverse effects | Arthritis, Rheumatoid - drug therapy | Antirheumatic Agents - adverse effects | Biosimilar Pharmaceuticals - pharmacokinetics | Adult | Antibodies - blood | Antirheumatic Agents - pharmacokinetics | Female | Aged | Antirheumatic Agents - therapeutic use | Therapeutic Equivalency | Viral antibodies | Treatment outcome | Care and treatment | Usage | Rheumatoid arthritis | Analysis | Antibodies | Dosage and administration | Methotrexate | Tumor necrosis factor-TNF | Biological products | Tuberculosis | Family medical history | Drug dosages | Index Medicus | Anti-TNF | DMARDs (biologic) | Disease Activity | Clinical and Epidemiological Research | Rheumatoid Arthritis | 1506
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10. Full Text Erythropoiesis‐stimulating agents for anaemia in adults with chronic kidney disease: a network meta‐analysis
by Palmer, Suetonia C and Saglimbene, Valeria and Mavridis, Dimitris and Salanti, Georgia and Craig, Jonathan C and Tonelli, Marcello and Wiebe, Natasha and Strippoli, Giovanni FM and Palmer, Suetonia C
Cochrane Database of Systematic Reviews, ISSN 1469-493X, 2014, Volume 2014, Issue 12, pp. CD010590 - CD010590
Hematinics | Hypertension | Kidney disease | Renal Insufficiency, Chronic | Erythropoietin | Polyethylene Glycols | Anemia | Chronic kidney disease | Recombinant Proteins | Biosimilar Pharmaceuticals | Anaemia control | Epoetin Alfa | General management | Darbepoetin alfa | Medicine General & Introductory Medical Sciences | Medicine, General & Internal | Life Sciences & Biomedicine | General & Internal Medicine | Science & Technology | Recombinant Proteins - therapeutic use | Hematinics - therapeutic use | Erythropoietin - therapeutic use | Humans | Erythropoietin - adverse effects | Polyethylene Glycols - adverse effects | Hematinics - adverse effects | Recombinant Proteins - adverse effects | Renal Insufficiency, Chronic - complications | Polyethylene Glycols - therapeutic use | Biosimilar Pharmaceuticals - adverse effects | Erythropoietin - analogs & derivatives | Anemia - drug therapy | Hypertension - chemically induced | Adult | Index Medicus
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