Results 11 to 20 of about 30,003 (287)
ESMO Open, 2018 Linked article: This is a commentary on P. Yamauchi et al., pp. 1066–1074 in this issue.
Sandeep, Parsad, Chadi, Nabhan
+11 more sources
Arquivos Brasileiros de Endocrinologia & Metabologia, 2011 Although common themes permeate the environment across continents and particular divergences as to how to proceed exist between different regulatory agencies, it seems that policies are still in flux. Not all polices will suffice to fit all dissimilar biologics, and these in place or being developed may, in turn, change to accommodate new or unexpected
openaire +6 more sources
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 ...
Nathalia Galli +4 more
openaire +3 more sources
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
TURKDERM, 2022 For a drug to be defined as a biosimilar, it should be fairly similar to the previously approved original or reference product. The minor variances in its inactive ingredients should not pose clinically significant differences from the reference product in terms of safety and efficacy potency.
openaire +3 more sources
Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines [PDF]
, 2018 Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations to identify challenges ...
Anvisa +20 more
core +5 more sources
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
What do oncologists need to know about biosimilar products?
Chinese Journal of Cancer, 2016 Many biologic products have improved the outcomes of cancer patients, but the costs can substantially burden healthcare systems. Biosimilar products can potentially reduce drug costs and increase patient access to beneficial treatments.
Linda K. S. Leung +3 more
doaj +1 more source