Sandoz’s biosimilar etanercept and rituximab show efficacy in new study

Sandoz has reported results from clinical studies showing the safety and efficacy of its new biosimilar etanercept and rituximab candidates.

The new drugs – based on the branded therapies Enbrel and MabThera, respectively – have achieved their primary endpoints of achieving pharmacokinetic bioequivalence to the originator products in two key clinical trials.

Etanercept and rituximab are indicated to treat autoimmune diseases such as rheumatoid arthritis, while rituximab can also be used in the treatment of haematological cancers such as follicular lymphoma.

No clinically meaningful differences in safety, tolerability and immunogenicity have been observed between the biosimilars and the original drugs, but biosimilars offer the key benefit of being much cheaper for patients.

Both therapies have been accepted for regulatory review by the European Medicines Agency. This supports Sandoz's goal of making ten regulatory filings for biosimilars between 2015 and 2017.

Malte Peters, head of global clinical development for biopharmaceuticals at Sandoz, said: "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."