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Sandoz biosimilars as safe and efficacious as originators, says early trials data

Published on 09/06/16 at 08:47am

Sandoz, a division of Novartis, has presented data at the Annual European Congress of Rheumatology (EULAR 2016) demonstrating the safety and efficacy of their biosimilar versions of autoimmune disease treatments, Enbrel (etanercept) and Mabthera (rituximab).

In both early stage studies, the Sandoz biosimilars achieved pharmacokinetic bioequivalence with no clinically meaningful differences in safety, tolerability and immunogenicity to the originator.

The company has already submitted biosimilar versions of these products to the EMA and FDA for approval. This latest data will reinforce these regulatory submissions for the exact same specifications as the reference products. Etanercept is approved to treat a range of autoimmune diseases such as rheumatoid arthritis and psoriasis. Mabtehra is approved in similar indications as well as a number of haematological cancers, like follicular lymphoma.

Malte Peters, head of global clinical development at Sandoz, says: “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. 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.”

Amgen filed a suit against Novartis in March, in an attempt to obstruct biosimilar competition for its blockbuster, Enbrel.

Sean Murray

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