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Items: 1 to 20 of 101

1.

Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin®) in patients with advanced non-squamous non-small cell lung cancer.

Li CSW, Sweeney K, Cronenberger C.

Cancer Chemother Pharmacol. 2019 Nov 26. doi: 10.1007/s00280-019-03946-8. [Epub ahead of print]

PMID:
31768697
2.

PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin®), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Study.

Reinmuth N, Bryl M, Bondarenko I, Syrigos K, Vladimirov V, Zereu M, Bair AH, Hilton F, Liau K, Kasahara K.

BioDrugs. 2019 Oct;33(5):555-570. doi: 10.1007/s40259-019-00363-4.

3.
4.

Population pharmacokinetics of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderately to severely active rheumatoid arthritis.

Palaparthy R, Rehman MI, von Richter O, Yin D.

Expert Opin Biol Ther. 2019 Oct;19(10):1065-1074. doi: 10.1080/14712598.2019.1635583. Epub 2019 Jul 8.

PMID:
31284794
5.

A phase I pharmacokinetics study comparing PF-06439535 (a potential biosimilar) with bevacizumab in healthy male volunteers.

Knight B, Rassam D, Liao S, Ewesuedo R.

Cancer Chemother Pharmacol. 2016 Apr;77(4):839-46. doi: 10.1007/s00280-016-3001-2. Epub 2016 Mar 16.

6.

A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera®) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL).

Sharman JP, Liberati AM, Ishizawa K, Khan T, Robbins J, Alcasid A, Rosenberg JA, Aurer I.

BioDrugs. 2019 Dec 9. doi: 10.1007/s40259-019-00398-7. [Epub ahead of print]

PMID:
31820339
7.

A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy.

Cohen SB, Alten R, Kameda H, Hala T, Radominski SC, Rehman MI, Palaparthy R, Schumacher K, Schmitt S, Hua SY, Ianos C, Sewell KL.

Arthritis Res Ther. 2018 Jul 27;20(1):155. doi: 10.1186/s13075-018-1646-4.

8.

Comparative nonclinical assessments of the proposed biosimilar PF-05280014 and trastuzumab (Herceptin(®)).

Hurst S, Ryan AM, Ng CK, McNally JM, Lorello LG, Finch GL, Leach MW, Ploch SA, Fohey JA, Smolarek TA.

BioDrugs. 2014 Oct;28(5):451-9. doi: 10.1007/s40259-014-0103-4.

9.

A randomized study comparing the pharmacokinetics of the potential biosimilar PF-06438179/GP1111 with Remicade® (infliximab) in healthy subjects (REFLECTIONS B537-01).

Palaparthy R, Udata C, Hua SY, Yin D, Cai CH, Salts S, Rehman MI, McClellan J, Meng X.

Expert Rev Clin Immunol. 2018 Apr;14(4):329-336. doi: 10.1080/1744666X.2018.1446829. Epub 2018 Mar 12.

PMID:
29504427
10.

A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis.

Fleischmann RM, Alten R, Pileckyte M, Lobello K, Hua SY, Cronenberger C, Alvarez D, Bock AE, Sewell KL.

Arthritis Res Ther. 2018 Aug 15;20(1):178. doi: 10.1186/s13075-018-1676-y.

11.

PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study.

Pegram MD, Bondarenko I, Zorzetto MMC, Hingmire S, Iwase H, Krivorotko PV, Lee KS, Li RK, Pikiel J, Aggarwal R, Ewesuedo R, Freyman A, Li R, Vana A, Yin D, Zacharchuk C, Tan-Chiu E.

Br J Cancer. 2019 Jan;120(2):172-182. doi: 10.1038/s41416-018-0340-2. Epub 2018 Dec 20.

12.

A Randomized, Double-Blind Trial Comparing the Pharmacokinetics of CT-P16, a Candidate Bevacizumab Biosimilar, with its Reference Product in Healthy Adult Males.

Cho SH, Han S, Ghim JL, Nam MS, Yu S, Park T, Kim S, Bae J, Shin JG.

BioDrugs. 2019 Apr;33(2):173-181. doi: 10.1007/s40259-019-00340-x.

PMID:
30850957
13.

A phase I pharmacokinetics trial comparing PF-05280586 (a potential biosimilar) and rituximab in patients with active rheumatoid arthritis.

Cohen S, Emery P, Greenwald M, Yin D, Becker JC, Melia LA, Li R, Gumbiner B, Thomas D, Spencer-Green G, Meng X.

Br J Clin Pharmacol. 2016 Jul;82(1):129-38. doi: 10.1111/bcp.12916. Epub 2016 Apr 29.

14.

A comparative pharmacokinetic study of DRL_BZ, a candidate biosimilar of bevacizumab, with Avastin® (EU and US) in healthy male subjects.

Wynne C, Schwabe C, Batra SS, Lopez-Lazaro L, Kankanwadi S.

Br J Clin Pharmacol. 2018 Oct;84(10):2352-2364. doi: 10.1111/bcp.13691. Epub 2018 Jul 26.

15.

A Global Phase I Clinical Study Comparing the Safety and Pharmacokinetics of Proposed Biosimilar BAT1706 and Bevacizumab (Avastin®) in Healthy Male Subjects.

Wu X, Wynne C, Xu C, Gan Y, Wang C, Thomas BE, Yu JC, Li S, Zhang L.

BioDrugs. 2019 Jun;33(3):335-342. doi: 10.1007/s40259-019-00352-7.

PMID:
31016568
16.

Nonclinical assessments of the potential biosimilar PF-06439535 and bevacizumab.

Peraza MA, Rule KE, Shiue MHI, Finch GL, Thibault S, Brown PR, Clarke DW, Leach MW.

Regul Toxicol Pharmacol. 2018 Jun;95:236-243. doi: 10.1016/j.yrtph.2018.03.020. Epub 2018 Mar 21.

17.

A randomized, single-blind, Phase I trial (INVICTAN-1) assessing the bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, in healthy subjects.

Hettema W, Wynne C, Lang B, Altendorfer M, Czeloth N, Lohmann R, Athalye S, Schliephake D.

Expert Opin Investig Drugs. 2017 Aug;26(8):889-896. doi: 10.1080/13543784.2017.1347635. Epub 2017 Jul 12.

PMID:
28651442
18.

Comparative assessment of clinical response in patients with rheumatoid arthritis between PF-05280586, a proposed rituximab biosimilar, and rituximab.

Williams JH, Hutmacher MM, Zierhut ML, Becker JC, Gumbiner B, Spencer-Green G, Melia LA, Liao KH, Suster M, Yin D, Li R, Meng X.

Br J Clin Pharmacol. 2016 Dec;82(6):1568-1579. doi: 10.1111/bcp.13094. Epub 2016 Sep 22.

19.

A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01).

Yin D, Barker KB, Li R, Meng X, Reich SD, Ricart AD, Rudin D, Taylor CT, Zacharchuk CM, Hansson AG.

Br J Clin Pharmacol. 2014 Dec;78(6):1281-90. doi: 10.1111/bcp.12464.

20.

Tolerance, variability, and pharmacokinetics of bevacizumab biosimilars in Chinese healthy male subjects.

Zhang H, Li Q, Zhu X, Li C, Li X, Liu C, Hu Y, Chen G, Wei H, Wang J, Shen Z, Ding Y.

Cancer Chemother Pharmacol. 2018 Oct;82(4):615-623. doi: 10.1007/s00280-018-3645-1. Epub 2018 Jul 24.

PMID:
30043208

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