FACILITY INSPECTIONS DELAY SANDOZ’S FILING FOR HUMIRA BIOSIMILAR IN US

Biosimilar News

Yesterday, during its Q4 2016 earnings call, Novartis CMO Vasant Narasimhan told investors that its subsidiary Sandoz had delayed filing its aBLA for a biosimilar of Humira® (adalimumab), which originally had been planned for Q4 2016.  According to Mr. Narasimhan, Sandoz has “pushed [the filing] into the first half of this year” “[b]ased on discussions with the FDA and ongoing capacity upgrades we’re making at our production site and the timing of regulatory inspections that would be required.”  Mr. Narasimhan further added that there are “no issues with our clinical data” and the delay is necessary “in order to time inspections appropriately for when our facility will be ready for those inspections[.]”

Novartis also reiterated its previous representations that FDA approval of Sandoz’s proposed pegfilgrastim biosimilar will likely be delayed until at least 2018 due to the need to complete a further study and submit data to FDA.  Mr. Narasimhan states: “As I’ve already told you previously with pegfilgrastim, we’re going to need to refile both in the U.S. and Europe, based on additional studies, the PK study that we need to complete, but we will be completing that and we’re on track to submit that in 2017 and 2018. 2017 for Europe and 2018 for the U.S.”

Stay tuned to Big Molecule Watch for further updates.

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