EMA accepts MAA for Sandoz’s biosimilar etanercept

8 December 2015  •  Author: Victoria White

The European Medicines Agency (EMA) has accepted Sandoz‘s Marketing Authorisation Application (MAA) for a biosimilar to Pfizer’s EU-licensed Enbrel (etanercept) – a tumour necrosis factor alpha (TNF-alpha) inhibitor.


Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis – more than 120 million people in the EU are living with rheumatic and musculoskeletal diseases (RMDs) and approximately 3.7 million Europeans with psoriasis.

“Today, only 5% of severe psoriasis patients in North America and Europe have access to life-changing biologic treatment options such as etanercept,”said Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz. “The acceptance by the EMA of our biosimilar etanercept regulatory submission is a move towards enabling more patients with chronic inflammatory conditions such psoriasis and rheumatoid arthritis to be treated with biologics” McCamish continued.

A comprehensive data package for biosimilar etanercept supports the application

The regulatory submission to the EMA consists of a comprehensive data package that includes data from analytical, functional, preclinical and clinical studies. Sandoz believes that the two pivotal clinical studies; a pharmacokinetic (PK) study in healthy volunteers (HVs) and a confirmatory safety and efficacy study in patients with chronic plaque-type psoriasis (EGALITY), will provide clinical confirmation of similarity to the reference product established in extensive prior analytical comparability studies.

Sandoz currently markets three biosimilars. On 3 September, 2015 Sandoz launched the first biosimilar in the United States and recently had its regulatory submissions for biosimilar etanercept and biosimilar pegfilgrastim accepted by the FDA. Sandoz has a leading pipeline with several biosimilars across the various stages of development including five programmes in Phase III clinical trials or registration preparation. The company plans to make 10 regulatory filings over a three year period (2015-2017).

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