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1.
Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer.
Breast Cancer Res Treat
; 188(2): 369-377, 2021 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-34125340
2.
Pharmacokinetic and pharmacodynamic bioequivalence of biosimilar MYL-1601D with US and European insulin aspart in healthy volunteers: A randomized, double-blind, crossover, euglycaemic glucose clamp study.
Diabetes Obes Metab
; 23(12): 2670-2678, 2021 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-34378861
3.
Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies.
BMC Endocr Disord
; 21(1): 129, 2021 Jun 26.
Artículo
en Inglés
| MEDLINE | ID: mdl-34174848
4.
Pharmacokinetic and pharmacodynamic bioequivalence of proposed biosimilar MYL-1501D with US and European insulin glargine formulations in patients with type 1 diabetes mellitus.
Diabetes Obes Metab
; 22(4): 521-529, 2020 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-31724253
5.
Efficacy and safety of MYL-1501D versus insulin glargine in people with type 1 diabetes mellitus: Results of the INSTRIDE 3 phase 3 switch study.
Diabetes Obes Metab
; 22(3): 365-372, 2020 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-31691472
6.
Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia.
Ann Hematol
; 98(5): 1217-1224, 2019 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-30824956
7.
Efficacy and safety of MYL-1501D versus insulin glargine in patients with type 2 diabetes after 24 weeks: Results of the phase III INSTRIDE 2 study.
Diabetes Obes Metab
; 21(1): 129-135, 2019 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-30112792
8.
Efficacy and safety of MYL-1501D vs insulin glargine in patients with type 1 diabetes after 52 weeks: Results of the INSTRIDE 1 phase III study.
Diabetes Obes Metab
; 20(8): 1944-1950, 2018 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-29656504
9.
A pharmacokinetics phase 1 bioequivalence study of the trastuzumab biosimilar MYL-1401O vs. EU-trastuzumab and US-trastuzumab.
Br J Clin Pharmacol
; 84(10): 2336-2343, 2018 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-29926514
10.
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.
JAMA
; 317(1): 37-47, 2017 01 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-27918780
11.
Population Pharmacokinetics of MYL-1402O, a Proposed Biosimilar to Bevacizumab and Reference Product (Avastin®) in Patients with Non-squamous Non-small Cell Lung Cancer.
Eur J Drug Metab Pharmacokinet
; 48(6): 675-689, 2023 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-37792130
12.
A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab.
J Cancer Res Clin Oncol
; 148(2): 487-496, 2022 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-33866430
13.
Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (Novolog®) in Patients with Type 1 Diabetes After 24 Weeks: A Randomized Open-Label Study.
BioDrugs
; 36(6): 761-772, 2022 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-36114990
14.
Phase III double-blind study comparing the efficacy and safety of proposed biosimilar MYL-1402O and reference bevacizumab in stage IV non-small-cell lung cancer.
Ther Adv Med Oncol
; 13: 17588359211045845, 2021.
Artículo
en Inglés
| MEDLINE | ID: mdl-34819997
15.
Physicochemical and functional characterization of MYL-1501D, a proposed biosimilar to insulin glargine.
PLoS One
; 16(6): e0253168, 2021.
Artículo
en Inglés
| MEDLINE | ID: mdl-34133466
16.
Correlation between week 24 trastuzumab-dkst response and week 48 progression-free survival: the HERITAGE trial.
Breast
; 58: 18-26, 2021 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-33892316
17.
Long-term efficacy and safety of itolizumab in patients with moderate-to-severe chronic plaque psoriasis: A double-blind, randomized-withdrawal, placebo-controlled study.
J Am Acad Dermatol
; 73(2): 331-3.e1, 2015 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-26183983
18.
Efficacy and safety of the vasopressin V1A/V2-receptor antagonist conivaptan in acute decompensated heart failure: a dose-ranging pilot study.
J Card Fail
; 14(8): 641-7, 2008 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-18926434
19.
Assessment of the efficacy and safety of intravenous conivaptan in patients with euvolaemic hyponatraemia: subgroup analysis of a randomized, controlled study.
Clin Endocrinol (Oxf)
; 69(1): 159-68, 2008 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-18034777
20.
A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim.
J Cancer Res Clin Oncol
; 144(6): 1087-1095, 2018 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-29671069