Investigational Humira Biosimilar Shows Efficacy in Plaque Psoriasis

Sandoz recently announced its proposed adalimumab (Humira) biosimilar, GP2017, showed similar efficacy compared with the reference product. Results from a phase 3 study demonstrated similar efficacy, safety, and immunogenicity between GP2017 and the reference product, according to a press release.

Included in the study were patients with moderate-to-severe chronic plaque psoriasis. The study was split into 3 treatment periods: first, patients were randomized to receive treatment with GP2017 or adalimumab for 17 weeks. In the second period, patients were re-randomized into 4 groups, with 2 groups continuing treatment and 2 switching treatments every 6 weeks until week 35. In the third period, patients received their initial treatment until week 51.

The study’s primary endpoint was the number of patients who achieved a 75% improvement in symptoms at week 16. The investigators found that 67% of patients treated with GP2017 achieved the benchmark, while only 65% of patients treated with adalimumab saw the improvement.

At week 17, the researchers noted similar safety and immunogenicity between the proposed biosimilar and the reference products.

Adverse events were similar between both groups, and were in line with adalimumab’s known safety profile, according to the press release. Adalimumab can cause adverse events, such as infections, hepatitis B virus, allergic reactions, nervous system problems, blood problems, heart failure, immune reactions, liver problems, or psoriasis, according to AbbVie, the drug’s manufacturer.

Adalimumab is indicated to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradentis supperativa, and uveitis. With GP2017 demonstrating similarity to the reference product, Sandoz plans to submit GP2017 for approval with the FDA and the European Medicines Agency this year, according to the press release.

Sandoz currently has 3 biosimilars marketed around the world, and plans to launch 5 new oncology and immunology biologics by 2020, the company stated in the release.

"Currently, it is estimated that as few as five percent of eligible psoriasis patients get the biologics they need" said Mark Levick, MD PhD, global head of Development, Biopharmaceuticals, Sandoz. "We are pleased the data reinforce the potential of our biosimilar adalimumab, if approved, to be another treatment option for moderate-to-severe chronic plaque psoriasis and other inflammatory diseases.”