Results 151 to 160 of about 22,015 (248)

Real-World Safety and Efficacy of Biosimilar Trastuzumab Emtansine (T-DM1) in HER2-Positive Breast Cancer: A Prospective Single-Institution Study From India. [PDF]

Int J Breast Cancer
Gandrala D, Rajappa SJ, Mallavarapu K, Santa A, Pavan Kumar B, Pinninti R, Ladda PS, Pathi N, Kandem S, Tewani RK, Thummar V, Mehta P.   +11 more
europepmc   +1 more source

Sandoz Inc. v. Amgen Inc.: Removing Barriers to Market Access for Biosimilar Manufacturers [PDF]

, 2019
Koya, Moyosore O.
core   +1 more source

Pharmacokinetic, Safety, and Immunogenicity Similarity of High‐ and Low‐Concentration Formulations of Adalimumab Biosimilar ABP 501, Adalimumab‐Atto

Pharmacology Research &Perspectives, Volume 14, Issue 2, April 2026.
Consistent with previously demonstrated similarity of biosimilar ABP 501 (adalimumab‐atto) with adalimumab reference product, this study in healthy adults demonstrates the pharmacokinetic, safety, and immunogenicity similarity of a high‐concentration formulation (100 mg/mL) of ABP 501 with the original 50mg/mL formulation.
Vincent Chow, Muhan Zhou, Daniel T. Mytych, Alexander Colbert, Mieke Jill Miller, Iwona Wala, Ahad Sabet, Waldemar Radziszewski   +7 more
wiley   +1 more source

Perceptions and clinical use of biosimilars among rheumatologists in ArLAR countries: a cross-sectional survey. [PDF]

Front Med (Lausanne)
Adnan A, Awadh NI, Humadi YA, Gorial FI, Ziade N, Younis AA, Hmamouchi I, El Kibbi L, Halabi H, Haouichat C, Masri BK, Omer EOH, Shimal AA, Al-Obaidi AD, Jassim NA.   +14 more
europepmc   +1 more source

Use of Modeling and Simulation to Inform the Development of Monoclonal Antibodies to Treat Moderate‐to‐Severe Asthma: A Retrospective Review of EMA Centralized Procedure From 2014 to 2024

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 4, April 2026.
ABSTRACT We present here a repository of key regulatory questions answered in centralized procedures and evaluate the place of modeling and simulation in marketing authorization process for biologics approved for the treatment of moderate‐to‐severe asthma from 2014 to 2024.
Hélène Haguet, Jean‐Michel Dogné, Flora T Musuamba   +2 more
wiley   +1 more source

Biologics and biosimilars medication errors in Saudi Arabia: a nationwide retrospective observational real-world study. [PDF]

Front Med (Lausanne)
Alshammri NT, Alluwaymi WS, Assiri GA, Alshammari TM.   +3 more
europepmc   +1 more source

Safety and Efficacy Assessment of Trastuzumab Emtansine in Indian Patients With Human Epidermal Growth Factor Receptor 2‐Positive Unresectable Locally Advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and a Taxane: An Open‐Label, Single‐Arm, Phase IV Study

Asia-Pacific Journal of Clinical Oncology, Volume 22, Issue 2, Page 240-250, April 2026.
A phase IV, single‐arm, open‐label, multicenter study assessing the safety and efficacy of trastuzumab emtansine in Indian patients for the treatment of human epidermal growth factor receptor 2 (HER2)‐positive unresectable locally advanced or metastatic breast cancer who received prior treatment with trastuzumab and a taxane.
Sudeep Gupta, Manish Singhal, Shona Nag, Waseem Abbas, Dinesh Chandra Doval, Hari Goyal, Chirag Shah, Ashish Singh, Radheshyam Naik, Nitesh Rohatgi, Poonam Patil, Shyam Aggarwal, Vinod Raina, Vaibhav Watts   +13 more
wiley   +1 more source

Biosimilars in Adult and Pediatric Noninfectious Uveitis. [PDF]

Clin Ophthalmol
Ploeger CG, Carvalho Soares Valentim C, Guner ME, Kabaalioglu Guner M.   +3 more
europepmc   +1 more source

Tafasitamab as Monotherapy or in Combination in Japanese Patients With B‐Cell Non‐Hodgkin Lymphoma: Results From the Phase 1b J‐MIND Study

Cancer Science, Volume 117, Issue 4, Page 1093-1105, April 2026.
J‐MIND evaluated the safety and tolerability of tafasitamab, a CD19‐targeting monoclonal antibody, alone or in combination with other therapies in Japanese patients with B‐cell non‐Hodgkin lymphoma (NHL). Most common treatment‐emergent adverse events across all groups were hematological, and no serious tafasitamab treatment‐related or fatal adverse ...
Koji Izutsu, Noriko Fukuhara, Junichiro Yuda, Youko Suehiro, Shigeru Kusumoto, Marie‐Laure Casadebaig, Kazumi Suzukawa, Kentaro Fukushima   +7 more
wiley   +1 more source

AVT04, a Biosimilar to Reference Product Ustekinumab, for the Treatment of Plaque Psoriasis: Insights from a Real-World Experience up to 28 Weeks. [PDF]

Dermatol Ther (Heidelb)
Mortato E, Talamonti M, Savastano L, Marcelli L, Tofani L, Gneo V, Marrapodi D, Ingrosso MR, Bianchi L, Galluzzo M.   +9 more
europepmc   +1 more source