Sandoz awaiting facility inspections before filing Humira biosimilar in US
During Novartis’s fourth quarter conference call yesterday, CMO Vasant Narasimhan told investors its subsidiary Sandoz pushed back its planned filing for its version of AbbVie’s Humira (adalimumab) biosimilar with the US Food and Drug Administration (FDA).
The Humira biosimilar was intended to be filed in Q4, he said, but “based 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, we have pushed that into the first half of this year.”
This is “in order to time inspections appropriately for when our facility will be ready for those inspections,” he continued, but added there are no issues with the candidate’s clinical data.
Biopharma-Reporter.com contacted Sandoz, and spokesman Chris Lewis confirmed the firm now intends to file its biosimilar adalimumab in the US later this year.
However, Lewis was unable to comment on the size or location of the manufacturing capacity upgrades.
“Manufacturing of Sandoz biosimilars is managed through the Novartis Biologics Technical Development and Manufacturing (BTDM) organisation, which has a global network,” he confirmed.
“There are three sites within the network historically dedicated to developing and manufacturing Sandoz biosimilars: Kundl and Schaftenau in Austria, plus Mengeš in Slovenia.”
Novartis has been vocal about its biologics site investments – which from 2010 to 2020 is expected to total more than €1bn – and in September 2015 completed a €150m fill/finish facility expansion at the Schaftenau site.
Legal wrangles and launches
The US has already approved one adalimumab biosimilar in September last year. But Amgen has said is unlikely to launch its product, Amjevita, until at least 2018 due to ongoing legal wrangles with reference drugmaker AbbVie.
And for similar reasons, Sandoz is unlikely to launch its approved etanercept biosimilar in the US this year according to a recent Reuters article which quoted Sandoz head Richard Francis.
Erelzi was approved as a biosimilar version of Amgen’s Enbrel by the FDA last August.