Switching Studies Show Efficacy of Multiple Sandoz Biosimilars

Sandoz recently announced positive findings from 4 clinical trials comparing its proposed biosimilars to their reference products, adalimumab (Humira) and rituximab (Rituxan), in the treatment of conditions such as psoriasis and rheumatoid arthritis (RA).

The results were recently presented at the American College of Rheumatology Annual Meeting, with 2 trials investigating switching and another 2 evaluating pharmacokinetics (PK) and pharmacodynamics (PD).

A phase 3 clinical trial that investigated the efficacy of switching between a proposed biosimilar and adalimumab met its primary endpoint of patients who achieved a 75% improvement at week 16. The impact of switching in patients with moderate-to-severe chronic plaque psoriasis was also examined.

This study included continuous and switching cohorts. The investigators found no clinical differences in efficacy, safety, and immunogenicity between patients who continuously received the biosimilar, those who were treated with reference adalimumab, and those who switched between the drugs, according to the release.

The other phase 3 switching study investigated rituximab in patients with RA, who already were previously treated with reference rituximab.

The investigators found that the rituximab biosimilar and the reference product had no differences in safety and immunogenicity for those who switched to the biosimilar and for those who continued treatment with the reference product, according to the release.

Sandoz reported that the phase 1 PK study met its primary endpoint of bioequivalence between adalimumab and the proposed biosimilar. The results also showed that the biosimilar matched the safety, tolerability, and immunogenicity of reference adalimumab.

Additionally, the PK and PD study in patients with RA met its primary endpoint. The study demonstrated PK bioequivalence and PD equivalence of the proposed biosimilar and reference rituximab, according to the release. The investigators found that there were no differences in efficacy, safety, and immunogenicity between the biosimilar and reference product.

Currently, Sandoz has 5 biosimilars marketed around the world, including a rituximab biosimilar—Rixathon—which was approved by the European Medicines Agency and is under review by the FDA, according to the release.

"Healthcare systems have a significant opportunity to deliver much-needed savings by switching to high-quality biosimilars," said Mark Levick, MD, PhD, global head of Development, Biopharmaceuticals, Sandoz. "Not only does the data presented demonstrate that our biosimilar adalimumab and biosimilar rituximab are important biologic alternatives for patients, but that physicians can switch to our biosimilars with confidence."