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news.The European Medicines Agency (EMA) has accepted Sandoz's marketing authorization application (MAA) for a biosimilar to Pfizer’s Enbrel (etanercept) to treat a range of autoimmune diseases.
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Novartis unit Sandoz is seeking approval for all indications included in the label of the reference product.
More than 120 million people in the European Union are living with rheumatic and musculoskeletal diseases and about 3.7 million Europeans with psoriasis.
Sandoz’s regulatory submission features a data package that includes data from analytical, functional, pre-clinical and clinical trials.
The EMA acceptance follows recent approval from the US Food and Drug Administration (FDA). It is the third of ten regulatory filings planned over 2015 to 2017.
Sandoz head of global biopharmaceutical & oncology injectables development Mark McCamish said: "Today, only 5% of severe psoriasis patients in North America and Europe have access to life-changing biologic treatment options such as etanercept.
"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."
Last month, the FDA accepted Sandoz’s biologics license application submission for its proposed biosimilar to Amgen’s Neulasta (pegfilgrastim) cancer drug.
The company is seeking approval for the similar indication as the reference product.