Biologics To Get Orange Book-style Reference Guide
This article was originally published in The Pink Sheet Daily
Color remains a mystery, but publication may come in handy soon as biosimilar sponsors are nearing the marketing application stage.
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The generic specialty injectables firm expects to file a biosimilar version of Amgen’s Epogen in the U.S. in late 2014, potentially positioning it for its first U.S. biosimilar launch in late 2015.
Having failed to significantly influence the design of the federal approval pathway, the Commission is hoping to have an impact on product naming and state substitution laws.
Halfway through the first year of the biosimilar user fee program, fee payments have not lived up to the expectation in President Obama’s FY 2013 budget request. Initial meetings continue to grow but at a slow pace, suggesting sponsors may remain hesitant about the pathway.