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Items: 1 to 20 of 138

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.
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
4.

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
6.

Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.

Blackwell K, Gascon P, Jones CM, Nixon A, Krendyukov A, Nakov R, Li Y, Harbeck N.

Ann Oncol. 2017 Sep 1;28(9):2272-2277. doi: 10.1093/annonc/mdx303.

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9.

A randomized, multicenter, phase II/III study to determine the optimal dose and to evaluate the efficacy and safety of pegteograstim (GCPGC) on chemotherapy-induced neutropenia compared to pegfilgrastim in breast cancer patients: KCSG PC10-09.

Lee KH, Kim JY, Lee MH, Han HS, Lim JH, Park KU, Park IH, Cho EK, Yoon SY, Kim JH, Choi IS, Park JH, Choi YJ, Kim HJ, Jung KH, Kim SY, Oh DY, Im SA.

Support Care Cancer. 2016 Apr;24(4):1709-17. doi: 10.1007/s00520-015-2963-7. Epub 2015 Oct 1.

10.

Cost-efficiency analyses for the US of biosimilar filgrastim-sndz, reference filgrastim, pegfilgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia.

McBride A, Campbell K, Bikkina M, MacDonald K, Abraham I, Balu S.

J Med Econ. 2017 Oct;20(10):1083-1093. doi: 10.1080/13696998.2017.1358173. Epub 2017 Aug 4.

PMID:
28722494
11.

Proposed biosimilar pegfilgrastim (LA-EP2006) compared with reference pegfilgrastim in Asian patients with breast cancer: an exploratory comparison from two Phase III trials.

Harbeck N, Gascon P, Jones CM, Nixon A, Krendyukov A, Nakov R, Li Y, Blackwell K.

Future Oncol. 2017 Jul;13(16):1385-1393. doi: 10.2217/fon-2017-0041. Epub 2017 Apr 28.

12.

An open-label, randomized, multicenter dose-finding study of once-per-cycle pegfilgrastim versus daily filgrastim in Chinese breast cancer patients receiving TAC chemotherapy.

Zhang W, Jiang Z, Wang L, Li C, Xia J.

Med Oncol. 2015 May;32(5):147. doi: 10.1007/s12032-015-0537-7. Epub 2015 Mar 29.

PMID:
25820754
13.

Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer.

Holmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, Glaspy J, Moore M, Meza L, Wiznitzer I, Neumann TA, Hill LR, Liang BC.

J Clin Oncol. 2002 Feb 1;20(3):727-31.

PMID:
11821454
14.

Safety and Efficacy of Pegfilgrastim When Given Less Than 14 Days Before the Next Chemotherapy Cycle: Review of Every 14-Day Chemotherapy Regimen Containing 5-FU Continuous Infusion.

Donkor KN, Selim JH, Waworuntu A, Lewis K.

Ann Pharmacother. 2017 Oct;51(10):840-847. doi: 10.1177/1060028017714554. Epub 2017 Jun 9.

PMID:
28597691
15.
16.

Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.

Harbeck N, Lipatov O, Frolova M, Udovitsa D, Topuzov E, Ganea-Motan DE, Nakov R, Singh P, Rudy A, Blackwell K.

Future Oncol. 2016 Jun;12(11):1359-67. doi: 10.2217/fon-2016-0016. Epub 2016 Mar 29.

17.

A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy.

Green MD, Koelbl H, Baselga J, Galid A, Guillem V, Gascon P, Siena S, Lalisang RI, Samonigg H, Clemens MR, Zani V, Liang BC, Renwick J, Piccart MJ; International Pegfilgrastim 749 Study Group.

Ann Oncol. 2003 Jan;14(1):29-35.

PMID:
12488289
18.

LA-EP2006: A Pegfilgrastim Biosimilar.

Hoy SM.

BioDrugs. 2019 Apr;33(2):229-232. doi: 10.1007/s40259-019-00348-3. Review.

PMID:
30887256
19.

A randomized, multi-center, open-label, phase III study of once-per-cycle DA-3031, a pegylated G-CSF, in comparison with daily filgrastim in patients receiving TAC chemotherapy for breast cancer.

Park KH, Lee S, Park JH, Kang SY, Kim HY, Park IH, Park YH, Im YH, Lee HJ, Park S, Lee SI, Jung KH, Kim YS, Seo JH.

Support Care Cancer. 2017 Feb;25(2):505-511. doi: 10.1007/s00520-016-3429-2. Epub 2016 Oct 6.

PMID:
27709313
20.

Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer.

Holmes FA, Jones SE, O'Shaughnessy J, Vukelja S, George T, Savin M, Richards D, Glaspy J, Meza L, Cohen G, Dhami M, Budman DR, Hackett J, Brassard M, Yang BB, Liang BC.

Ann Oncol. 2002 Jun;13(6):903-9.

PMID:
12123336

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