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
FDA on Biosimilars
No interferon beta biosimilars are yet on the market in Europe, but EMA is preparing for that eventuality by soliciting formal comment on a draft guidance it issued January 23. There are two interferon beta-1a drugs—Biogen Idec’s Avonex and Merck Serono’s Rebif—and two interferon beta-1b drugs—Betaseron made by Bayer HealthCare and Novartis’ Extavia, a copy of Betaseron that Novartis pays Bayer royalties to market. The EMA has slowly but surely developed guidelines for different types of biosimilars, while FDA is still working on finalizing the pathway for biosimilar approval in the U.S. The agency says it is in the final stages of issuing a draft guidance, though. What do you think of the situation in the U.S.?