Drug Development

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.

The statement:

Sandoz received a complete response letter from the FDA for biosimilar pegfilgrastim candidate (Neulasta). We are working with the agency to address remaining questions.

The regulatory roadblock is good news for Amgen, which earned $4.7 billion on the Neulasta franchise last year, its second biggest drug and a longtime earner that accounted for 22% of its product sales. Ironically, the regulatory stiff-arm was noted during a quarter in which generic competition to Novartis’ Gleevec hit hard.

It was a different biosimilar story for Novartis last week, though, as its biosimilar of Roche’s Enbrel received a warm welcome during an FDA panel review, likely signaling a near-term approval.

Just a month ago Novartis confidently outlined plans to launch its biosimilar of Neulasta in the near term, part of 5 approvals its subsidiary Sandoz was planning by 2020. Its early days yet, though, and Novartis can easily still make that work – depending on what the FDA found wrong with its application.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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