FDA Accepts BLA for Sandoz's Adalimumab Biosimilar

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.