Biosimilars Revolution

Biosimilars

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...

Biosimilars: Beginning a Conversation

In 2010, the Biologics Price Competition and Innovation (BPCI) Act was passed under the Patient Protection and Affordable Care Act (FDA, 2010). It created an abbreviated pathway for the approval of biologic products demonstrated to be clinically similar (or biosimilar) to or interchangeable with an approved reference product. A diverse panel of experts convened at JADPRO Live at APSHO to discus...