344 related articles for article (PubMed ID: 29671069)
21. A large multicentre, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologics.
Bellon A; Wang J; Skerjanec A; Velinova M; Dickerson D; Sabet A; Ngo L; O'Reilly T; Tomek C; Schussler S; Schier-Mumzhiu S; Gattu S; Koch SD; Schelcher C; Dobreva M; Boldea A; Nakov R; Otto GP
Br J Clin Pharmacol; 2020 Jun; 86(6):1139-1149. PubMed ID: 32022282
[TBL] [Abstract][Full Text] [Related]
22. Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta
Wynne C; Schwabe C; Vincent E; Schueler A; Ryding J; Ullmann M; Ghori V; Kanceva R; Stahl M
Pharmacol Res Perspect; 2020 Apr; 8(2):e00578. PubMed ID: 32333641
[TBL] [Abstract][Full Text] [Related]
23. PF-06881893 (Nivestym™), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen
Yao HM; Ottery FD; Borema T; Harris S; Levy J; May TB; Moosavi S; Zhang J; Summers M
BioDrugs; 2019 Apr; 33(2):207-220. PubMed ID: 30900158
[TBL] [Abstract][Full Text] [Related]
24. Comparison of effectiveness of biosimilar filgrastim (Nivestim™), reference Amgen filgrastim and pegfilgrastim in febrile neutropenia primary prevention in breast cancer patients treated with neo(adjuvant) TAC: a non-interventional cohort study.
Brito M; Esteves S; André R; Isidoro M; Moreira A
Support Care Cancer; 2016 Feb; 24(2):597-603. PubMed ID: 26111956
[TBL] [Abstract][Full Text] [Related]
25. Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy.
Desai K; Misra P; Kher S; Shah N
Exp Hematol Oncol; 2018; 7():22. PubMed ID: 30202638
[TBL] [Abstract][Full Text] [Related]
26. RGB-02 (biosimilar pegfilgrastim) in the treatment of chemotherapy-induced neutropenia.
Sántha D; Illés A; Aradi I; Horvát-Karajz K; Kahán Z
Future Oncol; 2019 Jun; 15(18):2083-2092. PubMed ID: 31210542
[TBL] [Abstract][Full Text] [Related]
27. Safety analysis of proposed pegfilgrastim biosimilar in Phase I and Phase III studies.
Harbeck N; Wang J; Otto GP; Gattu S; Krendyukov A
Future Oncol; 2019 Apr; 15(12):1313-1322. PubMed ID: 30834780
[No Abstract] [Full Text] [Related]
28. 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. PubMed ID: 28453299
[TBL] [Abstract][Full Text] [Related]
29. Sensitivity of Pegfilgrastim Pharmacokinetic and Pharmacodynamic Parameters to Product Differences in Similarity Studies.
Brekkan A; Lopez-Lazaro L; Plan EL; Nyberg J; Kankanwadi S; Karlsson MO
AAPS J; 2019 Jul; 21(5):85. PubMed ID: 31286293
[TBL] [Abstract][Full Text] [Related]
30. A review of the totality of evidence supporting the development and approval of a pegfilgrastim biosimilar (LA-EP2006).
Agarwala SS; Nagl U; Guo X; Bellon A; Heyn J; Dimova-Dobreva M; Shen YM; Schaffar G; Humphrey M; Mathieson N; Koptelova N; Gattu S
Curr Med Res Opin; 2022 Jun; 38(6):999-1009. PubMed ID: 35392751
[TBL] [Abstract][Full Text] [Related]
31. Comparison of pharmacokinetics, pharmacodynamics, safety, and immunogenicity of teriparatide biosimilar with EU- and US-approved teriparatide reference products in healthy men and postmenopausal women.
Fenwick S; Vekariya V; Patel R; Hajela P; Modi K; Kale P; Nath A
Osteoporos Int; 2023 Jan; 34(1):179-188. PubMed ID: 36287230
[TBL] [Abstract][Full Text] [Related]
32. 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. PubMed ID: 28722494
[TBL] [Abstract][Full Text] [Related]
33. Lipegfilgrastim: pharmacodynamics and pharmacokinetics for body-weight-adjusted and 6 mg fixed doses in two randomized studies in healthy volunteers.
Buchner A; Lammerich A; Abdolzade-Bavil A; Müller U; Bias P
Curr Med Res Opin; 2014 Dec; 30(12):2523-33. PubMed ID: 25251999
[TBL] [Abstract][Full Text] [Related]
34. 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.
Hövelmann U; Raiter Y; Chullikana A; Liu M; Donnelly C; Lawrence T; Sengupta N; Cl G; Ranganna G; Barve A
Diabetes Obes Metab; 2021 Dec; 23(12):2670-2678. PubMed ID: 34378861
[TBL] [Abstract][Full Text] [Related]
35. Pegfilgrastim-Apgf (Nyvepria): Biosimilar USFDA Approval for the Treatment of Chemotherapy-induced Febrile Neutropenia and Current Updates on Clinical Trials.
Ali F; Sharma K; Ali A
Curr Drug Targets; 2022; 23(9):924-932. PubMed ID: 35400340
[TBL] [Abstract][Full Text] [Related]
36. Comparison of biosimilar filgrastim with a reference product: pharmacokinetics, pharmacodynamics, and safety profiles in healthy volunteers.
Choi C; Yoo BW; Kim CO; Hong T; Jin BH; Seo KS; Jang JY; Park MS
Drug Des Devel Ther; 2018; 12():2381-2387. PubMed ID: 30122896
[TBL] [Abstract][Full Text] [Related]
37. A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab.
Hummel M; Bosje T; Shaw A; Liu MS; Barve A; Kothekar M; Socinski MA; Waller CF
J Cancer Res Clin Oncol; 2022 Feb; 148(2):487-496. PubMed ID: 33866430
[TBL] [Abstract][Full Text] [Related]
38. Phase I/II study to assess the clinical pharmacology and safety of single ascending and multiple subcutaneous doses of PF-06881894 in women with non-distantly metastatic breast cancer.
Yao HM; Jones SR; Morales S; Moosavi S; Zhang J; Freyman A; Ottery FD
Cancer Chemother Pharmacol; 2021 Dec; 88(6):1033-1048. PubMed ID: 34618197
[TBL] [Abstract][Full Text] [Related]
39. 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. PubMed ID: 27020170
[TBL] [Abstract][Full Text] [Related]
40. A pharmacokinetics phase 1 bioequivalence study of the trastuzumab biosimilar MYL-1401O vs. EU-trastuzumab and US-trastuzumab.
Waller CF; Vutikullird A; Lawrence TE; Shaw A; Liu MS; Baczkowski M; Sharma R; Barve A; Goyal P; Donnelly C; Sengupta N; Pennella EJ
Br J Clin Pharmacol; 2018 Oct; 84(10):2336-2343. PubMed ID: 29926514
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]
