Results 11 to 20 of about 21,799 (237)
Rheumatology International, 2014 Etanercept was the first tumour necrosis factor alpha antagonist approved in the USA for the treatment of rheumatoid arthritis, in 1998, and then for other diseases. With the etanercept patent set to expire in the EU in 2015, a number of etanercept copies have reached the production phase and are undergoing clinical trials, with the promise of being ...
Azevedo, Valderilio F. +4 more
openaire +2 more sources
Therapeutische Umschau, 2011 Die Bewertung von Biosimilars stellt eine Herausforderung für alle an der Zulassung und an der Arzneimittelauswahl Beteiligten im Gesundheitswesen dar. Bewertungskriterien sind wie bei allen Arzneimitteln Qualität, Wirksamkeit, Sicherheit/Verträglichkeit und Wirtschaftlichkeit.
openaire +6 more sources
Therapeutic Advances in Gastroenterology, 2023 Background: Many patients with inflammatory bowel disease (IBD) have transitioned from an infliximab originator to a biosimilar. However, some patients retransition to the originator (i.e. stop biosimilar and reinitiate the originator). Whether this sign
Rosanne W. Meijboom +6 more
doaj +1 more source
Evaluation of efficacy and comparative frequency of adverse events in patients with ulcerative colitis receiving the original infliximab and its biosimilar. One year of observation [PDF]
Терапевтический архив, 2019 Real - life data on the effectiveness and safety of biosimilar and biologic drugs licensed for treatment of inflammatory bowel diseases (IBD) is lacking. Aim.
O V Knyazev +7 more
doaj +1 more source
The Future of Generic Biologics: Should the United States “Follow-On” the European Pathway? [PDF]
, 2008 The United States is embarking on a biotechnology drug revolution. In the last few decades, biotech drugs have saved millions of lives, and the market for these miracle cures continues to grow at an astronomical rate.
Kaldre, Ingrid
core +4 more sources
The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA
Pharmaceutics, 2020 Biosimilar medicines expand the biotherapeutic market and improve patient access. This work looked into the landscape of the European and US biosimilar products, their regulatory authorization, market availability, and clinical evaluation undergone prior
Ioana Gherghescu +1 more
doaj +1 more source
Frontiers in Oncology, 2023 BackgroundBevacizumab has played an important role in the systemic treatment of patients with advanced non-small-cell lung cancer (NSCLC) without gene mutation.
Zhiting Zhao +11 more
doaj +1 more source
Forced Degradation Testing as Complementary Tool for Biosimilarity Assessment [PDF]
, 2019 Oxidation of monoclonal antibodies (mAbs) can impact their efficacy and may therefore represent critical quality attributes (CQA) that require evaluation.
Dyck, Yan Felix Karl +6 more
core +1 more source
Frontiers in Pharmacology, 2023 Background: Factors like the number of biosimilar competitors and competitive pricing strategies from originator companies may influence price competition and biosimilar uptake.Objective: The aim of this study was to analyze multiple facets of biosimilar
Elif Car +5 more
doaj +1 more source
Pharmacovigilance of Biosimilars [PDF]
, 2013 In lieu of an abstract, here is the article\u27s first paragraph: Biotech industry forms the backbone of the current pharmaceutical products. Seven out of top ten anticipated drugs of the industry in 2014 will be biologics [1].
Chablani, Lipika
core +2 more sources