Results 191 to 200 of about 790,096 (261)

Translating Asian-Dominant Pivotal Evidence Into EU Marketing Authorization: An EMA Regulatory Document Analysis, 2021-2025. [PDF]

Clin Transl Sci
Boruah P, Zwiers A.
europepmc   +1 more source

Comparison of pharmacokinetics, pharmacodynamics, safety, and immunogenicity of a candidate biosimilar INTP23.1 with EU and US‑approved denosumab reference products in healthy adult men. [PDF]

Naunyn Schmiedebergs Arch Pharmacol
Fenwick S, Parekh V, Shah N, Patel R, Kale P, Kolte S.   +5 more
europepmc   +1 more source

Population Pharmacokinetic Comparability of CT-P16 Versus EU-Avastin^® and US-Avastin^® in Healthy Subjects and Patients with Non-Squamous Non-Small Cell Lung Cancer. [PDF]

BioDrugs
Kim T, Kim H, Lee H, Ahn K, Park T, Baek H, Chang MJ.   +6 more
europepmc   +1 more source

The biologics manufacturing patent notice challenge: a comparative examination. [PDF]

J Law Biosci
Jefferson OA, Rai A.
europepmc   +1 more source

Development and preliminary physicochemical characterization of a Ramucirumab biosimilar candidate in CHO cells using shake-flask fed-batch culture. [PDF]

Bioprocess Biosyst Eng
Cagatay E, Gungor Y, Ozturk SS, Kayali HA.   +3 more
europepmc   +1 more source

Observational study of trastuzumab biosimilar in patients with HER2-positive breast cancer under routine clinical practice conditions in Morocco. [PDF]

BMC Cancer
Errihani H, Berrada N, El Bachiri M, Jouhadi H, Kabbaj O, Bourhafour M, Benider A, Khouchani M, Belbaraka G, Acharki A, Samlali R, Upveja KH.   +11 more
europepmc   +1 more source

Similarity assessment of disulfide isoform profiles between the romosozumab biosimilar and the reference medicinal product. [PDF]

Sci Rep
Zhao D, Liu Y, Wu C, Cao C, Zhou B, Lin Y, Liu Q, Li G, Shi J, Chen W, Lai Y, Li J.   +11 more
europepmc   +1 more source

Evaluating the feasibility of health care databases for assessing the safety of switching between originator biologics and biosimilars. [PDF]

J Manag Care Spec Pharm
Mendelsohn AB, DeFor TA, Audrey Djibo D, Myers SM, Pawloski PA, Lockhart CM.   +5 more
europepmc   +1 more source

Review of Quality Attributes and Analytical Methods Used for Comparative Analytical Assessment of Monoclonal Antibodies as Part of Successful Biosimilar Approvals in the United States and European Union. [PDF]

BioDrugs
Aithal R, Majedi OM, McCarthy D, Atouf F, Peckham N.   +4 more
europepmc   +1 more source

Short-term efficacy and safety of infliximab biosimilar (HS626) in inducing remission of inflammatory bowel disease: A real-world single-center study. [PDF]

Medicine (Baltimore)
Huang YS, Lai DP, Nong H, Zhang T, Chen ZY, Zeng WB, Huang XP, Lin YY.   +7 more
europepmc   +1 more source