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Items: 3

1.

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.

Ann Hematol. 2019 May;98(5):1217-1224. doi: 10.1007/s00277-019-03639-5. Epub 2019 Mar 1.

2.

Pegfilgrastim-jmdb/MYL-1401H: A Pegfilgrastim Biosimilar.

Hoy SM.

BioDrugs. 2019 Feb;33(1):117-120. doi: 10.1007/s40259-019-00334-9. Review.

PMID:
30701419
3.

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.

J Cancer Res Clin Oncol. 2018 Jun;144(6):1087-1095. doi: 10.1007/s00432-018-2643-3. Epub 2018 Apr 18.

PMID:
29671069

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