Regulatory evaluation of biosimilars: refinement of principles based on the scientific evidence and clinical experience
P Kurki, HN Kang, N Ekman, I Knezevic, M Weise… - BioDrugs, 2022 - Springer
Abstract The World Health Organization (WHO) guidelines on evaluation of similar
biotherapeutic products (SBPs; also called biosimilars) were adopted by the WHO Expert …
biotherapeutic products (SBPs; also called biosimilars) were adopted by the WHO Expert …
Immunomodulatory agents for treatment of patients with inflammatory bowel disease (review safety of anti-TNF, anti-integrin, anti IL-12/23, JAK inhibition, sphingosine …
L Sattler, SB Hanauer, L Malter - Current gastroenterology reports, 2021 - Springer
Abstract Purpose of the Review As treatment options for Inflammatory Bowel Disease (IBD)
expand each class of medication will have specific safety concerns and side-effect profiles …
expand each class of medication will have specific safety concerns and side-effect profiles …
ECCO position statement on the use of biosimilars for inflammatory bowel disease—an update
Biosimilars of infliximab were first approved by the European Medicine Agency in 2013, 1, 2
based on pre-clinical studies on biosimilarity and on clinical data coming from two …
based on pre-clinical studies on biosimilarity and on clinical data coming from two …
Long-Term Clinical Outcomes After Switching from Remicade® to Biosimilar CT-P13 in Inflammatory Bowel Disease
LJT Smits, A Grelack, LAAP Derikx, DJ de Jong… - Digestive diseases and …, 2017 - Springer
Background Limited data are available on long-term clinical outcomes regarding the switch
from Remicade® to the infliximab biosimilar CT-P13 in inflammatory bowel disease (IBD) …
from Remicade® to the infliximab biosimilar CT-P13 in inflammatory bowel disease (IBD) …
Biosimilars: harmonizing the approval guidelines
SK Niazi - Biologics, 2022 - mdpi.com
Biosimilar approval guidelines need rationalization and harmonization to remove the
inconsistencies and misconceptions to enable faster, safer, and more cost-effective …
inconsistencies and misconceptions to enable faster, safer, and more cost-effective …
Efficacy, safety and pharmacokinetics of biosimilars of anti-tumor necrosis factor-α agents in rheumatic diseases; A systematic review and meta-analysis
Y Komaki, A Yamada, F Komaki, P Kudaravalli… - Journal of …, 2017 - Elsevier
Objective To evaluate the efficacy and safety of biosimilars of anti-tumor necrosis factor
(TNF)-α agents compared to their reference agents in immune mediated diseases. Methods …
(TNF)-α agents compared to their reference agents in immune mediated diseases. Methods …
Effectiveness and safety of nonmedical switch from adalimumab originator to SB5 biosimilar in patients with inflammatory bowel diseases: twelve-month follow-up from …
G Tapete, L Bertani, A Pieraccini… - Inflammatory Bowel …, 2022 - academic.oup.com
Background Few data are currently available about SB5 in inflammatory bowel diseases
(IBD). The aim of this study was to assess the effectiveness and safety of SB5 in a cohort of …
(IBD). The aim of this study was to assess the effectiveness and safety of SB5 in a cohort of …
[HTML][HTML] Switching from an originator anti-TNF to a biosimilar in patients with inflammatory bowel disease: can it be recommended? A systematic review
JP Gisbert, M Chaparro - Gastroenterologia y Hepatologia, 2018 - Elsevier
Aim To review the effectiveness and safety of switching from an originator anti-TNF
(Remicade®) to a biosimilar (CT-P13) in patients with inflammatory bowel disease (IBD) …
(Remicade®) to a biosimilar (CT-P13) in patients with inflammatory bowel disease (IBD) …
Efficacy, pharmacokinetics, and immunogenicity is not affected by switching from infliximab originator to a biosimilar in pediatric patients with inflammatory bowel …
K van Hoeve, E Dreesen, I Hoffman… - Therapeutic Drug …, 2019 - journals.lww.com
Background: Rising evidence demonstrates that there are no differences in efficacy and
safety between infliximab (IFX) originator and IFX biosimilar CT-P13 in the treatment of …
safety between infliximab (IFX) originator and IFX biosimilar CT-P13 in the treatment of …
The argument against a biosimilar switch policy for infliximab in patients with inflammatory bowel disease living in Alberta
A nonmedical switch policy is currently being considered in Alberta, which would force
patients on originator biologics to biosimilar alternatives with the hypothetical aim of …
patients on originator biologics to biosimilar alternatives with the hypothetical aim of …