FDA Accepts Application for Adalimumab Biosimilar

Sandoz today announced that the FDA has accepted its biologics license application for a proposed adalimumab (Humira) biosimilar, according to a press release. The application was submitted under the 351(k) approval pathway.

The data package submitted to the FDA includes analytical, preclinical, and clinical trial data. These findings are expected to show that the Sandoz biosimilar matches the reference biologic in measures of safety, efficacy, and quality, according to the release.

Sandoz said that the clinical trial data submitted includes a pharmacokinetic study with healthy patients and a phase 3 safety and efficacy study in patients with moderate-to-severe chronic plaque psoriasis.

Reference adalimumab is indicated for inflammatory conditions such as rheumatoid arthritis, plaque psoriasis, Crohn’s disease, and ulcerative colitis, according to the release.

"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, global head of development, biopharmaceuticals, Sandoz. "The FDA's acceptance of the regulatory submission for our biosimilar adalimumab brings us one step closer to offering a portfolio of options to the millions of patients in the US who suffer from an inflammatory disease."

In September 2016, the FDA approved Amgen’s adalimumab-atto (Amjevita), but it was not deemed interchangeable. The FDA also issued approval to Boehringer Ingelheim’s adalimumab-adbm (Cyltezo) in August 2017.

Due to patent litigation, these drugs have yet to launch in the United States; however, the Amgen lawsuit was resolved and adalimumab-atto will launch in the United States on January 31, 2023.