FDA OKs Sandoz's Biosimilar Adalimumab-adaz

Officials with the FDA have approved Sandoz’s adalimumab-adaz (Hyrimoz), a biosimilar of Humira, according to a press release.

Adalimumab-adaz is indicated for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis in patients 4 years of age and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis.

Adalimumab, the active ingredient of Hyrimoz, is a tumor necrosis factor (TNF) inhibitor, according to Sandoz. Adalimumab-adaz targets and blocks the TNF protein that contributes to disease symptoms of autoimmune conditions, such as inflammation and tissue destruction.

Recent data from the ADMYRA phase 3 trial showed that adalimumab matched the reference biologic in terms of safety, efficacy, and immunogenicity in patients with moderate-to-severe RA at 24 weeks. The trial compared the efficacy and safety of the proposed biosimilar with its reference product in patients with an inadequate response to disease-modifying anti-rheumatic drugs, including methotrexate, up to week 48.

For the study, 353 patients received either 40 mg subcutaneous proposed biosimilar adalimumab or reference adalimumab biweekly up to week 22. According to the data, mean change from baseline at week 12 in Disease Activity Score, including high-sensitivity C-reactive protein (DAS28-CRP), was -2.16 for proposed biosimilar adalimumab (n=140) and -2.18 for reference adalimumab (n=144), meeting the study’s primary endpoint.

In a confirmatory efficacy and safety biosimilarity study (ADACCESS), adalimumab-adaz demonstrated therapeutic equivalence in patients with moderate-to-severe chronic plaque-type psoriasis, with a similar safety and immunogenicity profile to the reference biologic, according to Sandoz.

“Biosimilars can help people suffering from chronic debilitating conditions gain expanded access to important medicines that may change the outcomes of their disease,” Stefan Hendriks, global head of Biopharmaceuticals at Sandoz, said in a statement. “With the FDA approval of Hyrimoz, Sandoz is one step closer to offering US patients with autoimmune diseases the same critical access already available in Europe.”

This is the first approval of a biosimilar since July, when the FDA approved Pfizer’s filgrastim-aafi, a filgrastim biosimilar to Amgen's Neupogen. The agency also released its Biosimilar Action Plan, which aims to improve biosimilar competition in the marketplace through several key initiatives.

Reference

Sandoz receives US FDA approval of biosimilar Hyrimoz (adalimumab-adaz) [news release]. Sandoz’s website. https://www.sandoz.com/news/media-releases/sandoz-receives-us-fda-approval-biosimilar-hyrimoz-adalimumab-adaz. Accessed October 31, 2018.