238 related articles for article (PubMed ID: 29743182)
1. FDA's Approval of the First Biosimilar to Bevacizumab.
Casak SJ; Lemery SJ; Chung J; Fuchs C; Schrieber SJ; Chow ECY; Yuan W; Rodriguez L; Gwise T; Rowzee A; Lim S; Keegan P; McKee AE; Pazdur R
Clin Cancer Res; 2018 Sep; 24(18):4365-4370. PubMed ID: 29743182
[TBL] [Abstract][Full Text] [Related]
2. FDA's Approach to Regulating Biosimilars.
Lemery SJ; Ricci MS; Keegan P; McKee AE; Pazdur R
Clin Cancer Res; 2017 Apr; 23(8):1882-1885. PubMed ID: 28034906
[TBL] [Abstract][Full Text] [Related]
3. Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study.
He K; Chen H; Gwise T; Casak S; Lemery S; Keegan P; Pazdur R; Sridhara R
Clin Cancer Res; 2016 Nov; 22(21):5167-5170. PubMed ID: 27582485
[TBL] [Abstract][Full Text] [Related]
4. An FDA perspective on the assessment of proposed biosimilar therapeutic proteins in rheumatology.
Nikolov NP; Shapiro MA
Nat Rev Rheumatol; 2017 Feb; 13(2):123-128. PubMed ID: 28053335
[TBL] [Abstract][Full Text] [Related]
5. SB8, an approved bevacizumab biosimilar based on totality of evidence: scientific justification of extrapolation.
Peeters M; Lipp HP; Park M; Yoon YC; Arnold D
Future Oncol; 2023 Feb; 19(6):427-450. PubMed ID: 36883661
[TBL] [Abstract][Full Text] [Related]
6. Totality of evidence in the development of ABP 215, an approved bevacizumab biosimilar.
Thomas M; Thatcher N; Goldschmidt J; Ohe Y; McBride HJ; Hanes V
Immunotherapy; 2019 Oct; 11(15):1337-1351. PubMed ID: 31556762
[TBL] [Abstract][Full Text] [Related]
7. Bevacizumab biosimilars: scientific justification for extrapolation of indications.
Melosky B; Reardon DA; Nixon AB; Subramanian J; Bair AH; Jacobs I
Future Oncol; 2018 Oct; 14(24):2507-2520. PubMed ID: 29690784
[TBL] [Abstract][Full Text] [Related]
8. Clinical and Regulatory Considerations for the Use of Bevacizumab Biosimilars in Metastatic Colorectal Cancer.
Taïeb J; Aranda E; Raouf S; Dunn H; Arnold D
Clin Colorectal Cancer; 2021 Mar; 20(1):42-51.e3. PubMed ID: 33243618
[TBL] [Abstract][Full Text] [Related]
9. Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin
Li CSW; Sweeney K; Cronenberger C
Cancer Chemother Pharmacol; 2020 Mar; 85(3):487-499. PubMed ID: 31768697
[TBL] [Abstract][Full Text] [Related]
10. A Systematic Review of U.S. Biosimilar Approvals: What Evidence Does the FDA Require and How Are Manufacturers Responding?
Hung A; Vu Q; Mostovoy L
J Manag Care Spec Pharm; 2017 Dec; 23(12):1234-1244. PubMed ID: 29172975
[TBL] [Abstract][Full Text] [Related]
11. Midyear Commentary on Trends in Drug Delivery and Clinical Translational Medicine: Growth in Biosimilar (Complex Injectable Drug Formulation) Products Within Evolving Collaborative Regulatory Interagency (FDA, FTC, and DOJ) Practices and Enforcement.
Ho RJ
J Pharm Sci; 2017 Feb; 106(2):471-476. PubMed ID: 27876365
[TBL] [Abstract][Full Text] [Related]
12. Evaluating imbalances of adverse events during biosimilar development.
Vana AM; Freyman AW; Reich SD; Yin D; Li R; Anderson S; Jacobs IA; Zacharchuk CM; Ewesuedo R
MAbs; 2016 Jul; 8(5):861-6. PubMed ID: 27050730
[TBL] [Abstract][Full Text] [Related]
13. A randomized, double-blind, single-dose study to evaluate the biosimilarity of QL1101 with bevacizumab in healthy male subjects.
Liu YN; Huang J; Guo C; Yang S; Ye L; Wu ST; Zhang XF; Yang XY; Han CC; Pei Q; Huang L; He QN; Yang GP
Cancer Chemother Pharmacol; 2020 Mar; 85(3):555-562. PubMed ID: 31907645
[TBL] [Abstract][Full Text] [Related]
14. Comparative pharmacokinetics, efficacy, and safety of bevacizumab biosimilar to reference bevacizumab in patients with metastatic colorectal cancer.
Apsangikar PD; Chaudhry SR; Naik MM; Deoghare SB; Joseph J
Indian J Cancer; 2017; 54(3):535-538. PubMed ID: 29798953
[TBL] [Abstract][Full Text] [Related]
15. FKB238: A Bevacizumab Biosimilar.
Syed YY
Clin Drug Investig; 2021 Sep; 41(9):825-828. PubMed ID: 34347284
[TBL] [Abstract][Full Text] [Related]
16. Sowing confusion in the field: the interchangeable use of biosimilar terminology.
McKinley L; Kelton JM; Popovian R
Curr Med Res Opin; 2019 Apr; 35(4):619-621. PubMed ID: 30556742
[TBL] [Abstract][Full Text] [Related]
17. Real-world use of bevacizumab-awwb, a bevacizumab biosimilar, in US patients with metastatic colorectal cancer.
Rhodes W; DeClue RW; Accortt NA; Jin R; Sandschafer D; Wertz D; Patel K
Future Oncol; 2021 Dec; 17(36):5119-5127. PubMed ID: 34698523
[No Abstract] [Full Text] [Related]
18. A comparative pharmacokinetic study of DRL_BZ, a candidate biosimilar of bevacizumab, with Avastin
Wynne C; Schwabe C; Batra SS; Lopez-Lazaro L; Kankanwadi S
Br J Clin Pharmacol; 2018 Oct; 84(10):2352-2364. PubMed ID: 29943831
[TBL] [Abstract][Full Text] [Related]
19. Population Pharmacokinetics of MYL-1402O, a Proposed Biosimilar to Bevacizumab and Reference Product (Avastin
Owen JS; Rackley RJ; Hummel MA; Roepcke S; Huang H; Liu M; Idris TA; Murugesan SMN; Marwah A; Loganathan S; Ranganna G; Barve A; Waller CF; Socinski MA
Eur J Drug Metab Pharmacokinet; 2023 Nov; 48(6):675-689. PubMed ID: 37792130
[TBL] [Abstract][Full Text] [Related]
20.
; ; . PubMed ID:
[No Abstract] [Full Text] [Related]
[Next] [New Search]