Copies of Biological Medicines: Similar But Not the Same? von Kurki, Pekka

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Comparative efficacy studies of biosimilars: data versus theoretical risks, beliefs, and comfort von Kurki, Pekka

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Compatibility of immunogenicity guidance by the EMA and the US FDA von Kurki, Pekka

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Medication safety risks to be managed in national implementation of automatic substitution of biological medicines: a qualitative study von Tolonen, Hanna M, Airaksinen, Marja SA, Ruokoniemi, Päivi, Hämeen-Anttila, Katri, Shermock, Kenneth M, Kurki, Pekka

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Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective von Kurki, Pekka, Barry, Sean, Bourges, Ingrid, Tsantili, Panagiota, Wolff-Holz, Elena

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Biosimilars: the science of extrapolation von Weise, Martina, Kurki, Pekka, Wolff-Holz, Elena, Bielsky, Marie-Christine, Schneider, Christian K.

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Potential changes to the FDA approach to biosimilars have a global impact von Kurki, Pekka

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Interchangeability of Biosimilars: A European Perspective von Kurki, Pekka, van Aerts, Leon, Wolff-Holz, Elena, Giezen, Thijs, Skibeli, Venke, Weise, Martina

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EU Member States have tools to reduce costs of bestseller biologicals but can they use them? von Kurki, Pekka

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Physicians, Hippocrates and biosimilars: applying ancient principles in a modern society von Kurki, Pekka

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Biosimilars for prescribers von Kurki, Pekka

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Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience von Kurki, Pekka, Kang, Hye-Na, Ekman, Niklas, Knezevic, Ivana, Weise, Martina, Wolff-Holz, Elena

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No need for systematic switch studies to demonstrate interchangeability of biosimilars von Kurki, Pekka

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Immunogenicity Assessment of Biosimilars von Reinivuori, Tiina, Kurki, Pekka, Chamberlain, Paul

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Is There Any Research Evidence Beyond Surveys and Opinion Polls on Automatic Substitution of Biological Medicines? A Systematic Review von Tolonen, Hanna M., Falck, Jenni, Kurki, Pekka, Ruokoniemi, Päivi, Hämeen-Anttila, Katri, Shermock, Kenneth M., Airaksinen, Marja

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ECCO position challenged by European drug regulators von Kurki, Pekka, Bielsky, Marie-Christine

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2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK a... von Gupta, Shalini, Richards, Susan, Amaravadi, Lakshmi, Piccoli, Steven, Desilva, Binodh, Pillutla, Renuka, Stevenson, Lauren, Mehta, Devangi, Carrasco-Triguero, Montserrat, Neely, Robert, Partridge, Michael, Staack, Roland F, Zhao, Xuemei, Gorovits, Boris, Kolaitis, Gerry, Sumner, Giane, Stubenrauch, Kay-Gunnar, Zou, Linglong, Amur, Shashi, Beaver, Chris, Berger, Isabella, Berisha, Flora, Birnboeck, Herbert, Bower, Joe, Cho, Seongeun (Julia), Cludts, Isabelle, Cocea, Laurent, Donato, Lorella Di, Fischer, Saloumeh, Fraser, Stephanie, Garofolo, Fabio, Haidar, Sam, Haulenbeek, Jonathan, Hottenstein, Charles, Hu, Jenny, Ishii-Watabe, Akiko, Islam, Rafiq, Jani, Darshana, Kadavil, John, Kamerud, John, Kramer, Daniel, Kurki, Pekka, MacMannis, Stephen, McNally, Jim, Mullan, Ashley, Papadimitriou, Apollon, Pedras-Vasconcelos, João, Ray, Soma, Safavi, Afshin, Saito, Yoshiro, Savoie, Natasha, Fjording, Marianne Scheel, Scheibner, Kara, Smeraglia, John, Song, An, Stouffer, Bruce, Tampal, Nilufer, der Strate, Barry van, Verch, Thorsten, Welink, Jan, Xu, Yuanxin, Yang, Tong-yuan, Yengi, Lilian, Zeng, Jianing, Zhang, Yan, Zhang, Yanhua, Zoog, Stephen

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A European perspective on immunogenicity evaluation von Schneider, Christian K, Papaluca, Marisa, Kurki, Pekka

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2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regul... von Neubert, Hendrik, Olah, Timothy, Lee, Anita, Fraser, Stephanie, Dodge, Robert, Laterza, Omar, Szapacs, Matthew, Alley, Stephen C, Saad, Ola M, Amur, Shashi, Chen, Linzhi, Cherry, Elana, Cho, Seongeun (Julia), Cludts, Isabelle, Donato, Lorella Di, Edmison, Anna, Ferrari, Luca, Garofolo, Fabio, Haidar, Sam, Hopper, Shirley, Hottenstein, Scott, Ishii-Watabe, Akiko, Kassim, Sean, Kurki, Pekka, Lima Santos, Gustavo Mendes, Miscoria, Gilles, Palandra, Joe, Pedras-Vasconcelos, João, Piccoli, Steven, Rogstad, Sarah, Saito, Yoshiro, Savoie, Natasha, Sikorski, Timothy, Spitz, Susan, Staelens, Ludovicus, Verthelyi, Daniela, Vinter, Stephen, Wadhwa, Meenu, Wang, Yow-Ming, Welink, Jan, Weng, Naidong, Whale, Emma, Woolf, Eric, Wu, Jiang, Yan, Haoheng, Yu, Hongbin, Zhou, Shaolian

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2017 White Paper on Recent Issues in Bioanalysis: Rise of Hybrid LBA/LCMS Immunogenicity Assays (Part 2: Hybrid LBA/LCMS Biotherapeutics, Biomarkers & Immunogenicity Assays and Reg... von Neubert, Hendrik, Song, An, Lee, Anita, Wei, Cong, Duggan, Jeff, Xu, Keyang, Woolf, Eric, Evans, Chris, Palandra, Joe, Laterza, Omar, Amur, Shashi, Berger, Isabella, Bustard, Mark, Cancilla, Mark, Chen, Shang-Chiung, Cho, Seongeun (Julia), Ciccimaro, Eugene, Cludts, Isabelle, Cocea, Laurent, D’Arienzo, Celia, Danan-Leon, Lieza, Donato, Lorella Di, Garofolo, Fabio, Haidar, Sam, Ishii-Watabe, Akiko, Jiang, Hao, Kadavil, John, Kassim, Sean, Kurki, Pekka, Blaye, Olivier Le, Liu, Kai, Mathews, Rod, Lima Santos, Gustavo Mendes, Niwa, Makoto, Pedras-Vasconcelos, João, Qian, Mark, Rago, Brian, Saad, Ola, Saito, Yoshiro, Savoie, Natasha, Su, Dian, Szapacs, Matthew, Tampal, Nilufer, Vinter, Stephen, Wang, Jian, Welink, Jan, Whale, Emma, Wilson, Amanda, Xue, Y-J

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