Sanofi says the FDA has exceeded its authority and acted arbitrarily and capriciously in granting Momenta the right to market its version of the blood thinner.
Lovenox, of course, is Sanofi's best selling pharmaceutical with sales of more than $4.5 B annually. A generic competitor could cut deeply into those sales and market share.
In a statement, Sanofi said ".....The company believes that this case poses a number of significant questions regarding the FDA review process for complex pharmaceutical products which are important to pursue"
Translated - We don't like the decision when a generic biologic is being approved to compete against us. And everyone out there thought licensing of biologics and biosimilars was going to be easy.
Posted by Bruce Lehr July 27th 2010.