Early Birds Get FDA Worrying: How To Handle Quick Biosimilar Applications?
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Biosimilars: FDA Trying Group-Think Negotiating Strategy For User Fee
FDA seems content to negotiate a user fee for biosimilars in a manner that typifies the composition of the products: similar, but not the same, as the other user fee programs.
‘A Forever Battle:’ Patent Reform, Launch Prices, And Where Lower Rx Price Advocates Will Go Next
Pharma’s opponents believe passage of the Inflation Reduction Act represents a momentum shift that will make it easier for politicians (even some Republicans) to take on the industry. They’ll need to count on that as they still have a long list of targets ahead on their lower-drug pricing agenda.