This week, we’ve continued to outline the biotech industry trends we’ve been following on the Cross-Border Biotech Blog [1] and noting some recent developments and directions for 2011:
Transgenic plants and animals [2]continue 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 [3], 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.
That’s it for this week’s review of highlights and trends. Stay tuned to the The Cross-Border Biotech Blog [4] and @crossborderbio [5] on Twitter to see how it all shakes out