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.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
FDA Draft Guidance Removes Switching Study Requirements for Biosimilar Interchangeability
June 20th 2024The FDA has issued an update to its guidance on requiring switching study data for biosimilars to be granted interchangeability, citing new science that shows these studies aren’t needed to establish biosimilar safety.
British Columbia’s Biosimilar Switching Program Saves $732 Million in 5 Years
June 18th 2024British Columbia's 2019 Biosimilars Initiative, which transitioned over 40,000 patients from costly reference biologics to biosimilars, saved around $732 million in 5 years, maintained comparable health outcomes, and reinvested the savings to improve the province's public payer program.