Sandoz’s biosimilar etanercept accepted for EU regulatory review

Sandoz has announced that its new biosimilar version of etanercept has been accepted for regulatory review by the European Medicines Agency.

The European regulator has accepted the company's marketing authorisation application for the biosimilar version of Pfizer's approved anti-TNF therapy Enbrel, which is used to treat chronic inflammatory conditions.

Sandoz is seeking approval for all indications included in the label of the reference product, including rheumatoid arthritis and psoriasis, and has submitted clinical trial data showing its safety and efficacy.

It is hoped that the availability of a biosimilar version of this therapy will mean more patients can benefit from treatment for a much lower price.

Dr Mark McCamish, head of global biopharmaceutical and oncology injectables development at Sandoz, said: "The acceptance by the EMA of our biosimilar etanercept regulatory submission is a move towards enabling more patients with chronic inflammatory conditions … to be treated with biologics."

The firm launched its first biosimilar in the US in September and recently had its regulatory submissions for biosimilar etanercept and pegfilgrastim accepted by the US Food and Drug Administration.