201 related articles for article (PubMed ID: 36883661)
1. 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]
2. 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]
3. SB8: A Bevacizumab Biosimilar.
Syed YY
Target Oncol; 2020 Dec; 15(6):787-790. PubMed ID: 33206282
[TBL] [Abstract][Full Text] [Related]
4. 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]
5. The totality of evidence approach in the development of AVT02 (adalimumab), a biosimilar to Humira.
McClellan JE; Ómarsdóttir S; Roy N; Berger V; Michel C; Berti F
Ther Adv Chronic Dis; 2024; 15():20406223231223286. PubMed ID: 38250743
[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. 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]
8. A phase III, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB8 (proposed bevacizumab biosimilar) and reference bevacizumab in patients with metastatic or recurrent nonsquamous non-small cell lung cancer.
Reck M; Luft A; Bondarenko I; Shevnia S; Trukhin D; Kovalenko NV; Vacharadze K; Andrea F; Hontsa A; Choi J; Shin D
Lung Cancer; 2020 Aug; 146():12-18. PubMed ID: 32502923
[TBL] [Abstract][Full Text] [Related]
9. 'Totality of Evidence' Approach in the Development of GP2017, an Approved Adalimumab Biosimilar.
Gaylis N; Both C; Lemke L; von Richter O; Yamauchi P
Adv Ther; 2024 May; 41(5):1795-1814. PubMed ID: 38514505
[TBL] [Abstract][Full Text] [Related]
10. Scientific rationale for extrapolation of biosimilar data across cancer indications: case study of CT-P10.
Ogura M; Coiffier B; Kwon HC; Yoon SW
Future Oncol; 2017 May; 13(15s):45-53. PubMed ID: 28482699
[TBL] [Abstract][Full Text] [Related]
11. Evaluation of the Physico-Chemical and Biological Stability of SB8 (Aybintio), a Proposed Biosimilar to Bevacizumab, Under Ambient and In-Use Conditions.
Park D; Kim J; Yun J; Park SJ
Adv Ther; 2020 Oct; 37(10):4308-4324. PubMed ID: 32816233
[TBL] [Abstract][Full Text] [Related]
12. Biosimilars: Here and Now.
Lemery SJ; Esteva FJ; Weise M
Am Soc Clin Oncol Educ Book; 2016; 35():e151-7. PubMed ID: 27249717
[TBL] [Abstract][Full Text] [Related]
13. A review of the totality of evidence in the development of ABP 798, a rituximab biosimilar.
Cobb P; Niederwieser D; Cohen S; Hamm C; Burmester G; Seo N; Lehto SG; Hanes V
Immunotherapy; 2022 Jun; 14(9):727-740. PubMed ID: 35543293
[TBL] [Abstract][Full Text] [Related]
14. Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim.
Gascon P; Krendyukov A; Mathieson N; Natek M; Aapro M
BioDrugs; 2019 Dec; 33(6):635-645. PubMed ID: 31440986
[TBL] [Abstract][Full Text] [Related]
15. Biosimilars: Extrapolation for oncology.
Curigliano G; O'Connor DP; Rosenberg JA; Jacobs I
Crit Rev Oncol Hematol; 2016 Aug; 104():131-7. PubMed ID: 27354233
[TBL] [Abstract][Full Text] [Related]
16. Biosimilars and the extrapolation of indications for inflammatory conditions.
Tesser JR; Furst DE; Jacobs I
Biologics; 2017; 11():5-11. PubMed ID: 28255229
[TBL] [Abstract][Full Text] [Related]
17. A phase I, randomized, single-dose pharmacokinetic study comparing sb8 (bevacizumab biosimilar) with reference bevacizumab in healthy volunteers.
Shin D; Lee YJ; Choi J; Lee D; Park M; Petkova M
Cancer Chemother Pharmacol; 2020 Oct; 86(4):567-575. PubMed ID: 32949267
[TBL] [Abstract][Full Text] [Related]
18. Biosimilars in Inflammatory Bowel Disease: Facts and Fears of Extrapolation.
Ben-Horin S; Vande Casteele N; Schreiber S; Lakatos PL
Clin Gastroenterol Hepatol; 2016 Dec; 14(12):1685-1696. PubMed ID: 27215364
[TBL] [Abstract][Full Text] [Related]
19. Ten years of biosimilars in Europe: development and evolution of the regulatory pathways.
Schiestl M; Zabransky M; Sörgel F
Drug Des Devel Ther; 2017; 11():1509-1515. PubMed ID: 28553082
[TBL] [Abstract][Full Text] [Related]
20. Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation.
Scott BJ; Klein AV; Wang J
J Clin Pharmacol; 2015 Mar; 55 Suppl 3():S123-32. PubMed ID: 24965228
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
