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For: Lamanna WC, Holzmann J, Cohen HP, Guo X, Schweigler M, Stangler T, Seidl A, Schiestl M. Maintaining consistent quality and clinical performance of biopharmaceuticals. Expert Opinion on Biological Therapy 2018;18:369-79. [DOI: 10.1080/14712598.2018.1421169] [Cited by in Crossref: 26] [Cited by in F6Publishing: 22] [Article Influence: 6.5] [Reference Citation Analysis]
Number Citing Articles
1 Felix T, Jordan JB, Akers C, Patel B, Drago D. Current state of biologic pharmacovigilance in the European Union: improvements are needed. Expert Opinion on Drug Safety 2019;18:231-40. [DOI: 10.1080/14740338.2019.1577818] [Cited by in Crossref: 8] [Cited by in F6Publishing: 5] [Article Influence: 2.7] [Reference Citation Analysis]
2 Shatat SM, Al-Ghobashy MA, Fathalla FA, Abbas SS, Eltanany BM. Coupling of Trastuzumab chromatographic profiling with machine learning tools: A complementary approach for biosimilarity and stability assessment. J Chromatogr B Analyt Technol Biomed Life Sci 2021;1184:122976. [PMID: 34656909 DOI: 10.1016/j.jchromb.2021.122976] [Reference Citation Analysis]
3 Rojas-Chavarro LF, de Mora F. Extrapolation: Experience gained from original biologics. Drug Discov Today 2021;26:2003-13. [PMID: 34022458 DOI: 10.1016/j.drudis.2021.05.006] [Cited by in Crossref: 1] [Cited by in F6Publishing: 1] [Article Influence: 1.0] [Reference Citation Analysis]
4 Baranauskiene L, Kuo TC, Chen WY, Matulis D. Isothermal titration calorimetry for characterization of recombinant proteins. Curr Opin Biotechnol 2019;55:9-15. [PMID: 30031160 DOI: 10.1016/j.copbio.2018.06.003] [Cited by in Crossref: 9] [Cited by in F6Publishing: 8] [Article Influence: 2.3] [Reference Citation Analysis]
5 Tian M, Ticer T, Wang Q, Walker S, Pham A, Suh A, Busatto S, Davidovich I, Al-Kharboosh R, Lewis-Tuffin L, Ji B, Quinones-Hinojosa A, Talmon Y, Shapiro S, Rückert F, Wolfram J. Adipose-Derived Biogenic Nanoparticles for Suppression of Inflammation. Small 2020;16:e1904064. [PMID: 32067382 DOI: 10.1002/smll.201904064] [Cited by in Crossref: 17] [Cited by in F6Publishing: 16] [Article Influence: 8.5] [Reference Citation Analysis]
6 Krendyukov A, Schiestl M. Biosimilars in oncology: A decade of experience with granulocyte colony-stimulating factor and its implications for monoclonal antibodies. Crit Rev Oncol Hematol 2019;:102785. [PMID: 31405784 DOI: 10.1016/j.critrevonc.2019.07.009] [Cited by in Crossref: 2] [Cited by in F6Publishing: 1] [Article Influence: 0.7] [Reference Citation Analysis]
7 Cowper B, Lavén M, Hakkarainen B, Mulugeta E. Glycan analysis of erythropoiesis-stimulating agents. J Pharm Biomed Anal 2020;180:113031. [PMID: 31838284 DOI: 10.1016/j.jpba.2019.113031] [Cited by in Crossref: 2] [Cited by in F6Publishing: 2] [Article Influence: 0.7] [Reference Citation Analysis]
8 Webster CJ, George KL, Woollett GR. Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance. BioDrugs 2021;35:379-87. [PMID: 34143406 DOI: 10.1007/s40259-021-00488-5] [Reference Citation Analysis]
9 Alsamil AM, Giezen TJ, Egberts TC, Doevendans E, Leufkens HG, Gardarsdottir H. Nature and timing of post-approval manufacturing changes of tumour necrosis factor α inhibitor products: a 20-year follow-up study of originators and biosimilars. European Journal of Pharmaceutical Sciences 2022. [DOI: 10.1016/j.ejps.2022.106227] [Reference Citation Analysis]
10 Cohen HP, Lamanna WC, Schiestl M. Totality of Evidence and the Role of Clinical Studies in Establishing Biosimilarity. In: Gutka HJ, Yang H, Kakar S, editors. Biosimilars. Cham: Springer International Publishing; 2018. pp. 601-28. [DOI: 10.1007/978-3-319-99680-6_22] [Cited by in Crossref: 3] [Cited by in F6Publishing: 1] [Article Influence: 0.8] [Reference Citation Analysis]
11 Harsányi A, Csanádi M, Márky K, Vincziczki ÁZ, Kaló Z, Inotai A. Influence of biosimilar infliximab launch on the utilization pattern of biological medicines: the case of Hungary. Expert Rev Pharmacoecon Outcomes Res 2020;20:653-9. [PMID: 31510811 DOI: 10.1080/14737167.2019.1667232] [Cited by in Crossref: 2] [Cited by in F6Publishing: 2] [Article Influence: 0.7] [Reference Citation Analysis]
12 Webster CJ, Wong AC, Woollett GR. An Efficient Development Paradigm for Biosimilars. BioDrugs 2019;33:603-11. [PMID: 31388969 DOI: 10.1007/s40259-019-00371-4] [Cited by in Crossref: 14] [Cited by in F6Publishing: 9] [Article Influence: 7.0] [Reference Citation Analysis]
13 Prior S, Metcalfe C, Hufton SE, Wadhwa M, Schneider CK, Burns C. Maintaining 'standards' for biosimilar monoclonal antibodies. Nat Biotechnol 2021;39:276-80. [PMID: 33664522 DOI: 10.1038/s41587-021-00848-0] [Cited by in Crossref: 2] [Cited by in F6Publishing: 2] [Article Influence: 2.0] [Reference Citation Analysis]
14 Wadhwa M, Bird C, Atkinson E, Cludts I, Rigsby P. The First WHO International Standard for Adalimumab: Dual Role in Bioactivity and Therapeutic Drug Monitoring. Front Immunol 2021;12:636420. [PMID: 33936049 DOI: 10.3389/fimmu.2021.636420] [Cited by in Crossref: 1] [Cited by in F6Publishing: 1] [Article Influence: 1.0] [Reference Citation Analysis]
15 Metcalfe C, Dougall T, Bird C, Rigsby P, Behr-Gross ME, Wadhwa M, Study POT. The first World Health Organization International Standard for infliximab products: A step towards maintaining harmonized biological activity. MAbs 2019;11:13-25. [PMID: 30395763 DOI: 10.1080/19420862.2018.1532766] [Cited by in Crossref: 10] [Cited by in F6Publishing: 7] [Article Influence: 2.5] [Reference Citation Analysis]
16 Tu CL, Wang YL, Hu TM, Hsu LF. Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU- Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development? BioDrugs 2019;33:437-46. [PMID: 31111423 DOI: 10.1007/s40259-019-00357-2] [Cited by in Crossref: 5] [Cited by in F6Publishing: 3] [Article Influence: 1.7] [Reference Citation Analysis]
17 Cohen HP, McCabe D. The Importance of Countering Biosimilar Disparagement and Misinformation. BioDrugs 2020;34:407-14. [PMID: 32691270 DOI: 10.1007/s40259-020-00433-y] [Cited by in Crossref: 10] [Cited by in F6Publishing: 6] [Article Influence: 10.0] [Reference Citation Analysis]
18 Zhang Y, Mesa-Antunez P, Fortuin L, Andrén OCJ, Malkoch M. Degradable High Molecular Weight Monodisperse Dendritic Poly(ethylene glycols). Biomacromolecules 2020;21:4294-301. [PMID: 32845125 DOI: 10.1021/acs.biomac.0c01089] [Cited by in Crossref: 1] [Cited by in F6Publishing: 1] [Article Influence: 0.5] [Reference Citation Analysis]
19 Afzali A, Furtner D, Melsheimer R, Molloy PJ. The Automatic Substitution of Biosimilars: Definitions of Interchangeability are not Interchangeable. Adv Ther 2021;38:2077-93. [PMID: 33745111 DOI: 10.1007/s12325-021-01688-9] [Cited by in Crossref: 4] [Cited by in F6Publishing: 4] [Article Influence: 4.0] [Reference Citation Analysis]
20 Kaya SI, Cetinkaya A, Caglayan MG, Ozkan SA. Recent biopharmaceutical applications of capillary electrophoresis methods on recombinant DNA technology-based products. Electrophoresis 2021. [PMID: 34529858 DOI: 10.1002/elps.202100193] [Reference Citation Analysis]
21 Harris C, Xu W, Grassi L, Wang C, Markle A, Hardman C, Stevens R, Miro-Quesada G, Hatton D, Wang J. Identification and characterization of an IgG sequence variant with an 11 kDa heavy chain C-terminal extension using a combination of mass spectrometry and high-throughput sequencing analysis. MAbs 2019;11:1452-63. [PMID: 31570042 DOI: 10.1080/19420862.2019.1667740] [Cited by in Crossref: 3] [Cited by in F6Publishing: 2] [Article Influence: 1.0] [Reference Citation Analysis]
22 de Mora F, Balsa A, Cornide-Santos M, Carrascosa JM, Marsal S, P Gisbert J, Abad MA, F Duarte R, Wiechmann M, Martínez R. Biosimilar and interchangeable: Inseparable scientific concepts? Br J Clin Pharmacol 2019;85:2460-3. [PMID: 31486117 DOI: 10.1111/bcp.14089] [Cited by in Crossref: 6] [Cited by in F6Publishing: 5] [Article Influence: 2.0] [Reference Citation Analysis]
23 Ebbers HC, Fehrmann B, Ottosen M, Hvorslev N, Høier P, Hwang JW, Chung J, Lim HT, Lee S, Hong J, Rezk MF. Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars. BioDrugs 2020;34:225-33. [PMID: 31925703 DOI: 10.1007/s40259-019-00402-0] [Cited by in Crossref: 2] [Cited by in F6Publishing: 1] [Article Influence: 2.0] [Reference Citation Analysis]