EMA Accepts Sandoz’s Biosimilar for Etanercept

On Dec. 8, 2015, Sandoz, the generic pharmaceutical’s division of Novartis, announced that the European Medicines Agency (EMA) has accepted their marketing authorization application (MAA) for a biosimilar to Enbrel (etanercept), a tumor necrosis factor alpha (TNF-alpha) inhibitor.

According to a press release from the company, Sandoz is seeking approval for all indications included in the label of the reference product, which is authorized to treat autoimmune diseases-including rheumatoid arthritis and psoriasis. The regulatory submission to EMA consists of a comprehensive data package that includes data from analytical, functional, pre-clinical, and clinical studies.

Sandoz currently markets three biosimilars, including Zarxio, the first biosimilar approved for use in the United States. Zarxio was approved in September 2015 as a biosimilar of Amgen’s neutropenia medication Neupogen (filgrastim). The drug made headlines when global biopharmaceutical company, AbbVie, mentioned it in a Citizen’s Petition to FDA on the labeling practices of biosimilars. The petition affirms Zarxio’s label includes information from studies done on filgrastim, rather than Zarxio. The agency recently released an interim response to the petition, but has yet to release a formal statement.

Sandoz says the company plans to make 10 regulatory filings for biosimilar products in the next three years. 

Source: Sandoz