FDA Filing of Sandoz's Humira Biosimilar Delayed

Novartis’s generic subsidiary, Sandoz, has delayed its planned aBLA filing with the FDA for its Humira biosimilar of AbbVie’s adalimumab. Sandoz had intended to complete the filing in the last quarter of 2016, but has pushed it to the first half of 2017. Novartis Chief Medical Officer Vasant Narasimhan stated that the delay was necessary based on discussions with the FDA and ongoing capacity upgrades being made at Sandoz’s production site, along with considerations about the timing of required regulatory inspections.

Narasimhan said there are no issues with the clinical data associated with the biosimilar candidate adalimumab; rather, the delay was undertaken to time inspections appropriately for when the company’s facility will be ready for those inspection.

The size and location of the manufacturing upgrades is not clear. Sandoz’s biosimilars manufacturing is managed by Novartis Biologics Technical Development and Manufacturing, and three sites have been used for developing and manufacturing Sandoz biosimilars. Two are in Austria and one is in Slovenia.

To date, the FDA has approved only one adalimumab biosimilar—Amgen’s Amjevita—but that launch is unlikely to occur before 2018 because of AbbVie’s patent lawsuit against Amgen. Humira’s manufacturer, AbbVie, has raised the price of Humira eight times in the past few years, an increase of more than 70% (to approximately $49,000 annually before discounts. According to one analysis, by the end of 2015, a year’s treatment with Humira averaged $27,665 after discounts, up 49% from 3 years earlier—a monthly cost equaling more than many people’s mortgages.

Although the cost of a Humira biosimilar has not yet been determined, based on the costs of other approved biosimilars, the discount can be expected to be 15% of the cost of the reference drug, bringing the cost of adalimumab to about what Humira cost before the price hikes of the last several years took place.