Immunogenicity of Biosimilar Therapeutics in Drug Development

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Banerjee, R., Richards, A., Midha, S., Afrough, A., Anwer, F., Atanackovic, D., Atrash, S., Bachanova, V., Beitinjaneh, A. M., Ouchveridze, E., Castaneda Puglianini, O., Chhabra, S., Cicero, K. I., Davis, J. A., Dhakal, B., Dima, D., Ferreri, C. J., Forsberg, P. A., Freeman, C. L., … Kaur, G. (2025). Universal driving restrictions beyond 4 weeks appear unnecessary following CAR-T therapy in multiple myeloma. Blood Advances. https://doi.org/10.1182/bloodadvances.2025016131
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Gao, S., Bassil, D. T., Wagner, R. G., du Toit, J., Huber, H., Ashton, N. J., Cotton‐Samuel, D., Farrell, M. T., Mngomezulu, V., Manly, J. J., Tollman, S., Berkman, L. F., Zetterberg, H., & Brickman, A. M. (2024). Assessing the feasibility of dried blood spot (DBS) collection for blood‐based biomarkers of Alzheimer’s Disease in rural South Africa. Alzheimer’s & Dementia, 20(S2). Portico. https://doi.org/10.1002/alz.092596
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Davar, D., Williams, A., Lopez, J., Olson, D., Sato, T., Shaw, H., Friedman, C. F., Thistlethwaite, F., Middleton, M., Lebbe, C., Ma, V. T., Izar, B., Lau, P., Bechter, O., Kirk, P., Yuan, Y., Marshall, S., & Hamid, O. (2024). 694 Phase 1 safety and efficacy of brenetafusp, a PRAME × CD3 ImmTAC bispecific, in post-checkpoint cutaneous melanoma (CM). Regular and Young Investigator Award Abstracts, A796–A796. https://doi.org/10.1136/jitc-2024-sitc2024.0694
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Winter, H., Baldassano, R. N., Pfeffkorn, M. D., Wali, P., Verstraete, S. G., Picoraro, J. A., Washek, M. A., Kumar, N., Mortan, W., Havard- Jr, M., Blystone, L., Trombler, B., Pursley, C., Lin, X., Dillon, S. T., Gu, X., Otu, H. H., Ngo, L., & Libermann, T. A. (2024). P192 Personalizing treatment for predicting response to infliximab in children with Crohn’s disease using proteomic biomarkers. Journal of Crohn’s and Colitis, 18(Supplement_1), i506–i506. https://doi.org/10.1093/ecco-jcc/jjad212.0322
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Theodore, D., Neradilek, M., Gillespie, K., Edupuganti, S., Hinojosa, J. C., Lama, J. R., De La Grecca, R., Davis, A., Mangini, D. J., Andrew, P., Marovich, M., Zwerski, S., Castor, D., Roxby, A. C., Cohen, M., Corey, L., Huang, Y., Karuna, S., & Sobieszczyk, M. E. (2023). 1558. Associations between gender identity and solicited adverse events after passive infusion of VRC01 or placebo in HVTN 704/HPTN 085. Open Forum Infectious Diseases, 10(Supplement_2). https://doi.org/10.1093/ofid/ofad500.1393
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Midha, S., Gurumurthi, A., Costello, P., Redd, R. A., Freeman, C. L. L., Castaneda, O., Gonzalez, R., Ionescu, F., Gaballa, M., Kalariya, N., Khouri, J., Dima, D., Kocoglu, M. H., Sborov, D., Wagner, C. B., Atrash, S., Voorhees, P. M., Hashmi, H., Davis, J. A., … Patel, K. K. (2023). Alternative Lymphodepletion Strategies Lead to Similar Response Rates and Toxicities in Standard-of-Care BCMA-Directed CAR-T Therapy in Relapsed Refractory Multiple Myeloma. Blood, 142(Supplement 1), 3499–3499. https://doi.org/10.1182/blood-2023-187565
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Mejia Saldarriaga, M., Unkenholz, C., Fein, J. A., Monge, J., Rosenbaum, C., Pearse, R., Mapara, M., Inghirami, G., Lentzsch, S., Reshef, R., Niesvizky, R., & Bustoros, M. (2023). Post CAR-T Peripheral Lymphocytosis and Its Kinetics Are a Potential Biomarker for Response and Immune Mediated Toxicities. Blood, 142(Supplement 1), 3341–3341. https://doi.org/10.1182/blood-2023-187832
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Neelapu, S. S., Chavez, J. C., Sehgal, A. R., Epperla, N., Ulrickson, M. L., Bachy, E., Munshi, P. N., Casulo, C., Maloney, D. G., de Vos, S., Reshef, R., Leslie, L. A., Oluwole, O. O., Yakoub-Agha, I., Khanal, R., Rosenblatt, J. D., Peng, W., Lui, C., Wulff, J., … Jacobson, C. A. (2023). Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma: 4-Year Follow-up from the Phase 2 ZUMA-5 Trial. Blood, 142(Supplement 1), 4868–4868. https://doi.org/10.1182/blood-2023-174914
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Mena Lora, A. J., Long, J. E., Huang, Y., Baden, L. R., El Sahly, H. M., Follmann, D., Goepfert, P., Gray, G., Grinsztejn, B., Kotloff, K., Rouphael, N., Sobieszczyk, M., Walsh, S. R., Andriesen, J., Shah, K. A., Zhang, Y., Gilbert, P., Janes, H., Gay, C. L., … Wallace, S. E. (2023). Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials. JAMA Network Open, 6(1), e2251974. https://doi.org/10.1001/jamanetworkopen.2022.51974
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