Samsung Bioepis notches European Commission nod for Remicade biosim


Incheon-based Samsung Bioepis has won approval from the European Commission for its biosimilar of Remicade, marking its second anti-TNF-α therapy in the region.

The biosimilar of infliximab, dubbed Flixabi, is indicated to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, according to a press release from Samsung Bioepis.

Last week, the company said the U.S. FDA had accepted its biosimilar candidate of Johnson & Johnson's ($JNJ) Remicade for approval review.

In April, the candidate won a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use. It is now sold in Korea as Renflexis.

“With this approval, we are taking another important step in broadening affordable, high-quality biologic treatment options across Europe,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis.

The European Commission approval opens markets in each of the 28 European Union member states as well as the European Economic Area, which includes Norway, Iceland and Liechtenstein for Samsung Bioepis, a joint venture between majority partner South Korea's Samsung Biologics and Biogen ($BIIB).

Biogen will handle marketing in the region, Samsung Bioepis noted in the release.

The therapy, designated in-house as SB2, is one of 6 biosimilar candidates for the company either approved in regulated markets such as its biosim for Pfizer ($PFE)/Amgen's ($AMGN) Enbrel (etanercept), sold as Benepali in Europe, or on the regulatory pathway.

The other candidates are biosimilars of Sanofi's ($SNY) blockbuster insulin Lantus (insulin glargine), AbbVie's ($ABBV) autoimmune treatment Humira (adalimumab), Roche's ($RHHBY) breast cancer drug Herceptin (trastuzumab) and its multicancer drug Avastin (bevacizumab)--with another 7 molecules in early stages.

- here's the Samsung Bioepis website