Samsung Bioepis, the joint venture set up between the South Korean electronics giant and Biogen Idec, says a marketing authorisation application for SB4, its biosimilar of Amgen and Pfizer’s anti-TNF blockbuster Enbrel (etanercept) has been accepted by the European Medicines Agency.
The company notes that the acceptance of the file marks the first Enbrel (etanercept) biosimilar to get a regulatory review in the European Union. The MAA is based on results from a Phase III trial in patients with moderate-to-severe rheumatoid arthritis.
However, if authorised by the EMA, SB4 could be available for use in all of the same indications as Enbrel. As well as RA, it is already approved for a number of rheumatic diseases, including psoriasis, psoriatic arthritis, ankylosing spondylitis and certain forms of juvenile idiopathic arthritis.
If given the thumbs-up, SB4 will be sold in Europe by Biogen and produced at its facility in Denmark. Filings elsewhere are in the pipeline.
The branded drug is a huge earner for Amgen and licensee Pfizer, bringing in around $8.4 billion in total last year.