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Regulatory and clinical considerations for biosimilar oncology drugs.
Bennett CL, Chen B, Hermanson T, Wyatt MD, Schulz RM, Georgantopoulos P, Kessler S, Raisch DW, Qureshi ZP, Lu ZK, Love BL, Noxon V, Bobolts L, Armitage M, Bian J, Ray P, Ablin RJ, Hrushesky WJ, Macdougall IC, Sartor O, Armitage JO. Bennett CL, et al. Lancet Oncol. 2014 Dec;15(13):e594-e605. doi: 10.1016/S1470-2045(14)70365-1. Epub 2014 Nov 24. Lancet Oncol. 2014. PMID: 25456378 Free PMC article. Review.
Generic oncology drugs: are they all safe?
Yang YT, Nagai S, Chen BK, Qureshi ZP, Lebby AA, Kessler S, Georgantopoulos P, Raisch DW, Sartor O, Hermanson T, Kane RC, Hrushesky WJ, Riente JJ, Norris LB, Bobolts LR, Armitage JO, Bennett CL. Yang YT, et al. Among authors: bennett cl. Lancet Oncol. 2016 Nov;17(11):e493-e501. doi: 10.1016/S1470-2045(16)30384-9. Lancet Oncol. 2016. PMID: 27819247 Review.
Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada.
Chen B, Nagai S, Armitage JO, Witherspoon B, Nabhan C, Godwin AC, Yang YT, Kommalapati A, Tella SH, DeAngelis C, Raisch DW, Sartor O, Hrushesky WJ, Ray PS, Yarnold PR, Love BL, Norris LB, Knopf K, Bobolts L, Riente J, Luminari S, Kane RC, Hoque S, Bennett CL. Chen B, et al. Among authors: bennett cl. Oncologist. 2019 Apr;24(4):537-548. doi: 10.1634/theoncologist.2018-0341. Epub 2019 Mar 6. Oncologist. 2019. PMID: 30842244 Free PMC article.
Challenges to Biosimilar Substitution.
Chen B, Yang YT, Bennett CL. Chen B, et al. Among authors: bennett cl. JAMA. 2017 Sep 26;318(12):1186. doi: 10.1001/jama.2017.11930. JAMA. 2017. PMID: 28973608 No abstract available.
676 results