Novartis’ campaign to sweep biosimilar approvals hits a setback
Just as Novartis was leading the charge to open the floodgates on a wave of new biosimilar approvals, it hit a setback in the copycat wars. The pharma giant noted in its typically back-door fashion this morning that the FDA has rejected its application for pegfilgrastim, a generic version of Amgen’s Neulasta.
Novartis likes to bury bad pipeline news in any convenient hole, and it didn’t disappoint on that score, tossing it off in a liner at the end of a long list of recent accomplishments. Where most companies will at least put out a release on an FDA setback like this, Novartis prefers to slip these items into its quarterly updates. And in this case the CRL from the agency was briefly noted without even the slightest customary attempt to explain what might have gone wrong or when the company could plan to resubmit.
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