Results 161 to 170 of about 9,605 (202)

A Three-Arm, Tiered Comparability Strategy Bridging Post-Approval Process Changes for an Omalizumab Biosimilar (CMAB007). [PDF]

open access: yesPharmaceuticals (Basel)
Wang C   +10 more
europepmc   +1 more source

Biosimilars

Lupus, 2020
Biological therapies have widened the therapeutic armamentarium for immune-mediated inflammatory diseases, providing in many cases a broad range of treatment options with different mechanisms of action. The widespread use of biological agents in systemic lupus erythematosus is currently limited to belimumab and rituximab, although results of promising ...
Christopher J Edwards   +1 more
  +5 more sources

Biosimilar medicines

European Journal of Hospital Pharmacy, 2019
Biological medicines have become indispensable in the treatment of patients with serious diseases such as cancer and inflammatory diseases. Biosimilars are medicines which are developed to be similar to existing biological medicines (the 'reference product'). For the European market, they are approved by the European Medicines Agency.
András Süle   +4 more
openaire   +2 more sources

The Role of Biosimilars

Journal of the National Comprehensive Cancer Network, 2016
As biologics go off-patent, the field of oncology is grappling with incorporating biosimilars. These are highly similar (but not generic versions of) biologic agents, and they are approved based on showing "near fingerprint identity" in structure and potency. Their introduction is expected to increase competition and lower treatment costs.
Andrew D, Zelenetz, Pamela S, Becker
openaire   +2 more sources

The rise of the biosimilar

Expert Review of Clinical Pharmacology, 2012
Recombinant biologics have had an incredible impact on diseases such as arthritis and cancer by targeting specific receptors or disease mediators; however, access to these drugs is increasingly lim...
Mark, McCamish, Gillian, Woollett
openaire   +2 more sources

Biosimilars in India

Journal of Proteomics, 2015
Biosimilars have been defined as biotech drugs that have been shown to have comparable quality, safety and efficacy to the original product. The past decade has seen a significant increase in interest in these products from the biotech industry. Major developments have occurred with respect to establishing a regulatory path for approval of these ...
openaire   +2 more sources

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