Biosimilars for Etanercept and Rituximab Show Bioequivalence in Early Trial

Biosimilar candidates etanercept and rituximab found to be bioequivalent to original drugs Enbrel and MabThera, respectively, to treat autoimmune diseases and hematological cancers (rituximab).

The findings were found in a phase 1 trial of etanercept that demonstrated pharmacokinetic (PK) bioequivalence, as well as no clinically meaningful differences in tolerability, immunogenicity, and safety between etanercept and Enbrel.

During a phase 2 trial of rituximab, the candidate biosimilar also demonstrated PK bioequivalence and similar PD, efficacy, safety, and immunogenicity between rituximab and MabThera. The adverse events were similar in both medications.

“Findings from these studies, along with additional data in our development programs, demonstrate that our biosimilar etanercept and rituximab candidates are highly similar to their originators,” said Malte Peters, head of Global Clinical Development, Biopharmaceuticals, at Sandoz. “Access to biological therapies remains a challenge for many patients with immunological disorders such as rheumatoid arthritis and blood cancers like follicular lymphoma. If approved, our biosimilars could help broaden access to these vital therapies.”