Samsung Bioepis announced that the European Medicines Agency (EMA) had accepted the biosimilar – known as SB4 – for review last week, explaining that if approved Biogen Idec will produce the drug for the European market at its plant in Hillerød, Denmark.
A Biogen Idec spokeswoman told BioPharma-Reporter.com “We have an agreement with Samsung Bioepis to produce three anti-TNF biosimilar candidates at the facility, of which SB4 is the first.”
The Hillerød site houses 90,000 litres of stainless steel bioreactor capacity and produces Bioen Idec’s own range of biopharmaceuticals including Tysabri (natalizumab) and Avonex (interferon beta-1a).
The spokeswoman also confirmed that clinical trial supplies of SB4 had been manufactured at the site.
Samsung and Biogen teamed up to develop biosimilars in 2010 in a deal that melded the former’s “business acumen” with the latter’s “expertise in biologics” according to Samsung Biologics CEO, Tae-Han Kim.
The 2010 agreement – which saw Biogen exercise its right to commercialize anti-TNF biosimilars in Europe in 2013 – also meant Samsung would not target any of the US drugmaker’s originator products.
Samsung is seeking approval for SB4 as an alternative treatment for moderate-to-severe rheumatoid arthritis. However, if the drug is cleared, Samsung has indicated its intention to seek regulatory go ahead in other indications for which Amgen’s Enbrel is approved.
Samsung Bioepis – which was set up in 2012 as a joint venture between Samsung Biologics and Biogen – also said it plans to seek approval for SB4 in other markets.
SB4 is the first Enbrel biosimilar submitted for regulatory review in Europe, but it is not likely to be the last as European patents for the drug expire next month and a number of other drugmakers are already developing copycats.
For example, In 2011 Merck & Co teamed up with South Korea’s Hanwa to create a biosimilar version of Enbrel. However, the deal collapsed a year later after Amgen – which licenses the drug from Roche – was granted a patent extension by the USPTO.
More recently, Indian generics firm Cipla launched a biosimilar version of Enbrel in India. The product – named Etacept – is manufactured by the firm’s Chinese partner Shanghai Guojian Pharmaceutical Co and is sold for 30% less than the innovator drug.
In September 2013, Baxter and Coherus Biosciences teamed up to develop a version of Enbrel, but Baxter is not the only company with which Coherus is trying to create an Enbrel copy.
In May 2012 the firm announced that Japan’s Daiichi Sankyo had agreed to develop a biosimilar version of the drug – as well as a version of Rituxan – for several Asian markets.