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Pegfilgrastim-jmdb/MYL-1401H: A Pegfilgrastim Biosimilar.
Hoy SM. Hoy SM. BioDrugs. 2019 Feb;33(1):117-120. doi: 10.1007/s40259-019-00334-9. BioDrugs. 2019. PMID: 30701419 Review.
Pegfilgrastim-jmdb/MYL-1401H (FULPHILA) [hereafter referred to as pegfilgrastim-jmdb] is a biosimilar of the reference pegylated recombinant granulocyte colony-stimulating factor pegfilgrastim. ...
Pegfilgrastim-jmdb/MYL-1401H (FULPHILA) [hereafter referred to as pegfilgrastim-jmdb] is a biosimilar of the reference pegylat …
Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia.
Waller CF, Ranganna GM, Pennella EJ, Blakeley C, Bronchud MH, Mattano LA Jr, Berzoy O, Voitko N, Shparyk Y, Lytvyn I, Rusyn A, Popov V, Láng I, Beckmann K, Sharma R, Baczkowski M, Kothekar M, Barve A. Waller CF, et al. Ann Hematol. 2019 May;98(5):1217-1224. doi: 10.1007/s00277-019-03639-5. Epub 2019 Mar 1. Ann Hematol. 2019. PMID: 30824956 Free PMC article. Clinical Trial.
This was a phase 3, multicenter, randomized, double-blind, parallel-group equivalence trial of MYL-1401H vs European Union-sourced reference pegfilgrastim. Patients with newly diagnosed stage II/III breast cancer eligible to receive (neo) adjuvant chemotherapy with …
This was a phase 3, multicenter, randomized, double-blind, parallel-group equivalence trial of MYL-1401H vs European Union-sou …
A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim.
Waller CF, Tiessen RG, Lawrence TE, Shaw A, Liu MS, Sharma R, Baczkowski M, Kothekar MA, Micales CE, Barve A, Ranganna GM, Pennella EJ. Waller CF, et al. J Cancer Res Clin Oncol. 2018 Jun;144(6):1087-1095. doi: 10.1007/s00432-018-2643-3. Epub 2018 Apr 18. J Cancer Res Clin Oncol. 2018. PMID: 29671069 Clinical Trial.
METHODS: This phase 1, randomized, double-blind, three-way crossover trial in healthy volunteers evaluated the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of the proposed biosimilar, comparing MYL-1401H, reference pegfilgrastim (Neulasta() …
METHODS: This phase 1, randomized, double-blind, three-way crossover trial in healthy volunteers evaluated the pharmacokinetics (PK), pharma …
Physicochemical stability study of MYL-1401O, a biosimilar of trastuzumab, following a transient temperature excursion.
Guyader GL, Vieillard V, Paul M. Guyader GL, et al. J Oncol Pharm Pract. 2021 Jun;27(4):847-856. doi: 10.1177/1078155220940410. Epub 2020 Jul 13. J Oncol Pharm Pract. 2021. PMID: 32660375
INTRODUCTION: The extended stability of the trastuzumab biosimilar Ogivri (MYL-1401O; trastuzumab-dkst) was studied under different storage conditions, including following reconstitution of the lyophilized powder (21 mg/mL) but undiluted and stored in vials at 4C; after di …
INTRODUCTION: The extended stability of the trastuzumab biosimilar Ogivri (MYL-1401O; trastuzumab-dkst) was studied under different s …