The EMA’s acceptance follows recent US FDA regulatory submission acceptance
Sandoz announced that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA) for a biosimilar to Pfizer’s EU-licensed Enbrel (etanercept) * – a tumour necrosis factor alpha (TNF-alpha) inhibitor.
The company 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. According to reports, more than 120 million people in the EU are living with rheumatic and musculoskeletal diseases (RMDs) and approximately 3.7 million Europeans with psoriasis.
The EMA’s acceptance follows recent US FDA regulatory submission acceptance and is the third of 10 regulatory filings planned over a three year period ending 2017.
The regulatory submission to the EMA consists of a comprehensive data package that includes data from analytical, functional, pre-clinical 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.