SB4 - A Second Biosimilar Up For Review in Europe Save

A biosimilar of etanercept (Enbrel) made by the South Korean company Samsung Bioepis is under consideration by regulators in the European Union. Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, is taking aim with its version of etanercept. Their application for the biosimilar etanercept (known as SB4) is being assessed by the European Medicines Agency (EMA) this week, according to the EMA agenda.

Worldwide sales of Amgen's Enbrel totaled $9 billion last year, with Europe accounting for about $2.5 billion.

SB4 (etanercept) data on clinical efficacy, safety, immunogenicity and the radiographic findings was presented at the 2015 ACR meeting (Abstract #2055).

Biosimilar etanercept, which was recently approved in South Korea, would be the second such antibody product to reach the market in Europe and its arrival is likely to intensify competition. European doctors are already able to prescribe biosimilar infliximab, a copy of Merck's Remicade.
The infliximab biosimilar is gaining ground in certain European countries after some surprisingly steep price discounts. In some cases, these have reached nearly 70 percent, though overall the discounts have been nearer 45 percent.

Assuming biosimilar etanercept is given a green light from the EMA this week, its approval will still have to be formally ratified by the European Commission, a process that normally takes a couple of months.

Biogen will market the drug in Europe and manufacture it at a factory in Denmark.