Issue 4/2023
Content (11 Articles)
Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009–2022
Ryosuke Kuribayashi, Ayuki Nakano, Aya Hariu, Yasuhiro Kishioka, Futaba Honda
Base Editing and Prime Editing: Potential Therapeutic Options for Rare and Common Diseases
Lauren C. Testa, Kiran Musunuru
Lupus Nephritis: New and Emerging Biologic and Targeted Therapies
Ajinath Kale, Maciej Lech, Hans-Joachim Anders, Anil Bhanudas Gaikwad
The Role of Biologics in the Treatment of Chronic Rhinosinusitis
Nora Haloob, Katerina Karamali, Claire Hopkins
Novel Immunotherapeutic Approaches for the Treatment of Glioblastoma
Saïf Eddine Zaidi, Eliese Moelker, Kirit Singh, Aditya Mohan, Miguel A. Salgado, Muhammed Amir Essibayi, Kelly Hotchkiss, Steven Shen, William Lee, John Sampson, Mustafa Khasraw
Antibody–Drug Conjugates in the Treatment of Urothelial Cancer
Avani M. Singh, Jose A. Guevara-Patino, Xuefeng Wang, Roger Li, Guru Sonpavde, Rohit K. Jain
CAR-T Cells and the Kidney: Insights from the WHO Safety Database
Alexandre O. Gérard, Diane Merino, Alexis Charbinat, Joseph Fournier, Alexandre Destere, Michael Loschi, Thomas Cluzeau, Antoine Sicard, Milou-Daniel Drici
Factors Associated with Biosimilar Exclusions and Step Therapy Restrictions Among US Commercial Health Plans
Tianzhou Yu, Shihan Jin, Chang Li, James D. Chambers, Jakub P. Hlávka
Recurring Fatigue After Biologic Administration: Patient-Reported Data from the Dutch Biologic Monitor
Jette A. van Lint, Naomi T. Jessurun, Sander W. Tas, Harald E. Vonkeman, Martijn B. A. van Doorn, Frank Hoentjen, Michael T. Nurmohamed, Eugene P. van Puijenbroek, Bart J. F. van den Bemt
Assessing the Interchangeability of AVT02 and Humira® in Participants with Moderate‑to‑Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicenter, Double-Blind, Randomized, Parallel-Group Study
Steven R. Feldman, Richard Kay, Nataliya Reznichenko, Joanna Sobierska, Roshan Dias, Hendrik Otto, Halimu N. Haliduola, Abid Sattar, Ruth Ruffieux, Heimo Stroissnig, Fausto Berti
Characterization for the Similarity Assessment between Proposed Biosimilar SB12 and Eculizumab Reference Product Using a State-of-the-Art Analytical Method
Hyunsoo Kim, Eunkyoung Hong, Jungmin Lee, Seokku Hong, Jihye Kim, Miju Cho, Yikwon Kim, Taekyung Yoo