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
Despite delays by the FDA and some opposition from originator companies, biosimilars now represent one of the most rapidly evolving areas of product development in the biopharmaceutical industry. Amgen’s Enbrel had been talked about as one of the first complex biologics likely to appear in a biosimilar form, with protection assumed to expire in late 2012 in the U.S. and in 2015 in Europe. On November 22, however, Amgen reported that a patent for the fusion protein that is Enbrel had just been extended by 17 years. Biosimilar companies with large stakes in antibody development, however, are still likely to challenge the ’182 patent or come up with ways to circumvent it. Who do you think will succeed?