Results 91 to 100 of about 166 (149)

Translating Asian‐Dominant Pivotal Evidence Into EU Marketing Authorization: An EMA Regulatory Document Analysis, 2021–2025

Clinical and Translational Science, Volume 19, Issue 8, August 2026.
ABSTRACT An increasing number of novel molecular entities and biosimilars reach the European Medicines Agency (EMA) supported by pivotal evidence derived predominantly from Asian patient populations. This creates regulatory challenges that the existing ICH E5 framework was not originally designed to address.
Prerona Boruah, Alex Zwiers
wiley   +1 more source

Impact of biosimilar medicinal products in the EU pharmaceutical market [PDF]

Clinical Therapeutics, 2015
A. Grozdanova, K. Ancevska Netkovska, Z. Sterjev, Z. Naumovska, A. Kapedanovska Nestorovska, L.j Suturkova   +5 more
openaire   +1 more source

Five‐Year Outcomes and Disease Trajectories in Moderate‐to‐Severe Ulcerative Colitis: A Korean Multicenter Inception Cohort

Journal of Gastroenterology and Hepatology, Volume 41, Issue 8, Page 2338-2348, August 2026.
ABSTRACT Background and Aim The incidence of ulcerative colitis (UC) has been increasing in Asia. Comprehensive data on the long‐term course of moderate‐to‐severe UC remain scarce. This study investigated the clinical outcomes and factors associated with a disabling disease course in Korean patients with moderate‐to‐severe UC.
Byong Duk Ye, Hyo Jong Kim, Dong Il Park, Young Sook Park, Kang‐Moon Lee, Jong Pil Im, Sung‐Ae Jung, Yoon Tae Jeen, Jae Myung Cha, Jae Hee Cheon, Sung Noh Hong, Youngdoe Kim, Jong Min Choi, YoungJa Lee, Chang Kyun Lee   +14 more
wiley   +1 more source

REGULATORY AND ANALYTICAL SCIENCE OF BIOSIMILARS: A PHARMACEUTICAL CHEMISTRY PERSPECTIVE

The development and approval of biosimilars represent a significant advancement in pharmaceutical science, offering cost-effective therapeutic alternatives to originator biologics. From a pharmaceutical chemistry perspective, the regulatory and analytical evaluation of biosimilars demands a rigorous, multidisciplinary approach to ensure comparable ...
openaire   +2 more sources

Nonclinical Similarity of the Biosimilar Candidate ABP 938 with Aflibercept Reference Product

Ophthalmology and Therapy
Introduction ABP 938 is being developed as a biosimilar to Eylea® (aflibercept reference product [RP]), an anti-vascular endothelial growth factor (VEGF) drug used in the management of retinal diseases.
Neungseon Seo, Scott Kuhns, Dina A. Andrews, Alexander Colbert, Vincent Chow, Jennifer Liu   +5 more
doaj   +1 more source

Analytical similarity as the primary determinant of monoclonal antibody development: toward evidence-efficient regulatory frameworks

Frontiers in Drug Delivery
Monoclonal antibodies (mAbs) constitute the most rapidly expanding and therapeutically impactful class of biological medicines, driven by their exceptional target specificity, modular engineering capabilities, predictable pharmacokinetics facilitated by ...
Sarfaraz K. Niazi
doaj   +1 more source

Budget impact analysis of natalizumab biosimilar on pharmaceutical expenditure for the treatment of relapsing-remitting multiple sclerosis in Italy

AboutOpen
Background: The availability of high-efficacy disease-modifying therapy (DMT), including natalizumab, improved treatment efficacy in adults with highly-active relapsing-remitting multiple sclerosis (RRMS). Natalizumab patent protection has expired, and the natalizumab biosimilar (Tyruko®) has been recently reimbursed by AIFA.
Roberto Bergamaschi, Marco Capobianco, Roberto Ravasio   +2 more
openaire   +2 more sources

A Cure for All Ills? The Effectiveness of Therapeutic and Biosimilar Pharmaceutical Competition in the Netherlands

European Pharmaceutical Law Review, 2020
Sauter, Wolf, Akker, Ilan
openaire   +2 more sources

Treatment Persistence and Switching Patterns of Adalimumab Biosimilar ABP 501 in European Patients with Rheumatologic Diseases

Rheumatology and Therapy
Introduction ABP 501 was an adalimumab (ADA) biosimilar approved for treating immune-mediated inflammatory diseases (IMIDs) including rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS).
Ran Jin, Silvia Kruppert, Florian Scholz, Isabelle Bardoulat, Khalil Karzazi, Francois Morand, Greg Kricorian, David Collier, Jonathan Kay   +8 more
doaj   +1 more source

Biosimilar drugs - reimbursement regulations. Polish ISPOR chapter’s Therapeutic Programs and Pharmaceutical Care (TPPC) task force report

Journal of Health Policy & Outcomes Research, 2013
Objectives: Due to the increased number in biosimilar drugs getting marketing authorization, there is a question to be answered which reimbursement procedure should be followed. Methods: The TPPC task force has checked the approach to biosimilar drugs by WHO, at the EMA level and in a few countries worldwide.
openaire   +1 more source