Etanercept biosimilars

Biosimilars

"Total evidence" network meta-analysis as a tool for improving the assessment of biosimilars: application to etanercept in rheumatoid arthritis
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Since biosimilars generally have undergone less clinical research than originators, their place in therapy can be strengthened by increasing the amount of clinical evidence supporting their approval. This report describes an approach in which a "total evidence" network meta-analysis is performed that compares the biosimilar not only with the originator but also with the previous standard of car...

Getting Familiar With Biosimilars

Biotechnology has revolutionized the treatment of many chronic and acute illnesses, including cancer. The latest advance comes in the form of biosimilars. At the JADPRO Live at APSHO conference, Kelley D. Mayden, MSN, FNP, AOCNP, of Wellmont Cancer Institute, Bristol, Virginia, gave an A-to-Z talk about these drugs and what they mean for the advanced practitioner in oncology. “The science of cr...

Bioanalytical challenges of biosimilars.

Biologics such as monoclonal antibodies and recombinant proteins represent a significant portion of the pharmaceutical market. With many of the first generation biologics' patents expiring, an increasing number of biosimilars will be submitted for approval in the near future. The successful development of a biosimilar requires the demonstration of biosimilarity in terms of efficacy, safety and ...

Coming of Age: Biosimilars.

by Szilard Kiss, MD; and Jennifer Krawitz, MD The 20-year clock on drug patents begins ticking upon the invention of a drug, rather than upon drug approval by the U.S. Food and Drug Administration (FDA). The process of FDA approval is lengthy: pushing a novel medication through phase 1, 2, and 3 trials can often approach 8 or more years. Just over a decade ago, the dawn of the anti-vascular end...