Monday, September 30, 2013
Biosimilars developers, manufacturers of originator biologics,
payers and consumer groups are battling in state capitals, at FDA
headquarters, and at the World
Health Organization in Geneva over the rules that will shape
perceptions and prescribing practices for copycat biologics in the U.S. and
around the world.
Separately, none of the
conflicts will have a decisive effect on either biosimilars developers or
manufacturers of the products they hope to replace. But collectively, state
laws on interchangeable biosimilar substitution, national and international
naming practices, and FDA's labeling policies could have powerful effects on
the market penetration of biosimilars.