Individual Tumor Profiling
Has Tumor Molecular Profiling Enabled More Effective and Less Toxic Cancer Treatment?
Top 10 Under 40
Up-and-Coming Stars Shine in Biopharma Research and Business
Podcast: FDA’s New Commissioner Hits the Ground Running
Scott Gottlieb, M.D., Commits to Speeding Up Drug Reviews, and Maintaining Safety and Efficacy
Liquid Biopsies Remain Wait and See for Some Clinicians
Circulating Biomarker Assays Promise to Refresh Cancer Profiling and Monitoring Practices
Legislation on Biosimilars
Brand-name firms ask for significant clinical trial data before approval to ensure the new versions are true copies with the closest possible safety profile and efficacy. They’d also like at least 14 years of market exclusivity to ensure the ability to generate profits after a long and costly development process. Companies focusing on biosimilars would prefer to avoid going through every clinical trial phase, stating that proving safety and efficacy can be done in a quicker manner. And of course, they want to get their biosimilars on the market asap. Politicians are currently reviewing a proposal that would confer at least five years of market exclusivity. So where do you stand?