FDA should expect more submissions as US biosimilar doors open, says consultant
Sandoz’s recommendation was an “inevitable step” in the introduction of biosimilars to the US, and the US FDA should expect more submissions according to a consultant.
Archives for January 23, 2015
Australia doubles back on biosimilar naming conventions to follow WHO move
Australia’s TGA (Therapeutic Goods Administration) is shifting its stance on the way it plans to name biosimilars to keep the country more in line with the WHO’s (World Health Organization) proposed policies.
Pre-competitive groups don't compete; Amgen and Lundbeck join group behind the HELM platform
Competition is not a problem in the pre-competitive collaboration space according to the Pistoia Alliance, a non-profit R&D innovation focused group that has signed up Amgen and Lundbeck as its latest members.