Sandoz, a division of Novartis, announced today that the FDA has accepted its Biologics License Application (BLA) for a proposed adalimumab biosimilar (referencing AbbVie’s Humira).
Sandoz, a division of Novartis, announced today that the FDA has accepted its Biologics License Application (BLA) for a proposed adalimumab biosimilar (referencing AbbVie’s Humira). Sandoz reports that its comprehensive data package includes analytical as well as preclinical and clinical data, and that the submission is expected to demonstrate that the biosimilar matches the reference in terms of safety, efficacy, and quality.
"When patients are dealing with a chronic disease, it is imperative they have access to important medication that will help best manage their health," said Mark Levick, MD, PhD, global head of development, biopharmaceuticals, Sandoz, in a statement. "The FDA's acceptance of the regulatory submission for our biosimilar adalimumab brings us [1] step closer to offering a portfolio of options to the millions of patients in the [United States] who suffer from an inflammatory disease."
Clinical data in the submission include a pharmacokinetic study in healthy volunteers and a phase 3 confirmatory safety and efficacy study (ADACCES) in patients with moderate to severe chronic plaque psoriasis. In November 2017, Sandoz announced that the study met its primary endpoint in the proportion of patients who had achieved a 75% improvement in their condition at week 16 of treatment, as measured by the Psoriasis Area and Severity Index, or PASI. The study design included contiguous treatment and switched treatment arms, and the findings confirmed that there were no clinically significant differences in efficacy, safety, or immunogenicity among patients who received the biosimilar continuously, those who received the reference Humira continuously, and those who switched between the biosimilar and its reference multiple times.
Sandoz has not announced whether its study was designed to provide a basis on which the proposed therapy could be approved as an interchangeable biosimilar, but the FDA’s yet-to-be-finalized guidance on demonstrating interchangeability holds that data from switching studies be conducted in sensitive populations and include at least 3 switches.
If its biosimilar is approved, Sandoz will join Amgen (sponsor of Amgevita) and Boehringer Ingelheim (sponsor of Cyltezo) in having a challenger to the blockbuster Humira, and may also face a long wait to bring its biosimilar to market; Amgevita will not launch in the United States until 2023, and no date for Cyltezo’s launch has been announced. Meanwhile, the latest price increase to the reference Humira has been estimated by 1 analyst as having the potential to cost the US health system $1 billion in 2018 alone.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.