Samsung Bioepis biosimilar may get nod in Europe

A biosimilar copy of Amgen's ($AMGN) Enbrel made by South Korea's Samsung Bioepis could be recommended for approval as soon as Friday (Nov. 20) for use in Europe, according to a report by Reuters. The move comes just days after the company said its Brenzys (SB4) biosimilar and others showed comparable safety and efficacy to the original products.

In addition to Brenzys, Samsung Bioepis said in a press release that its version of Johnson & Johnson's ($JNJ) Remicade (infliximab) also had a safety profile comparable to the original product, and its SB5 biosimilar version of AbbVie's ($ABBV) Humira (adalimumab) "demonstrated both equivalent efficacy and comparable safety [to the original product] in a 24-week Phase III clinical study."

"The one-year clinical studies for SB4 and SB2 investigational biosimilar candidates provide encouraging indications of their comparable safety profiles," Christopher Hansung Ko, CEO of Samsung Bioepis, said in the release.

Enbrel has global sales worth $9 billion with $2.5 billion of that coming from Europe, according to the Reuters report, which added that the European Medicines Agency is reviewing the marketing application submitted by Samsung Bioepis.

- here's the release
- here's the story from Reuters