This week, we’ve continued to outline the biotech industry trends we’ve been following on the Cross-Border Biotech Blog and noting some recent developments and directions for 2011:
Transgenic plants and animalscontinue to generate some of the most fascinating new science and technology and continue to generate considerable controversy. Canadian expertise contributed to the AcquaVantage salmon and the Enviropig; but the regulatory and legal environment lags behind the science in this area, and things in the U.S. are getting worse instead of better.
Biosimilars are also growing in importance, with FDA guidance pending and even biotech stalwarts Amgen and Biogen-Idec entering the category. Still, the U.S. made the data exclusivity period so long, it drove at least one manufacturer to treat a biosimilar as a brand new drug and submit to the full FDA approval process.