Samsung Bioepis' biosim of Remicade clears regulatory hurdle in EU
- Samsung Bioepis' biosimilar version of infliximab won a positive recommendation from the European Medicine Agency on Friday, setting up a future marketing approval from the European Commission, the company said. The drug will be marketed as Flixabi.
- Johnson and Johnson's branded infliximab, Remicade, has been a major drug for the treatment of rheumatoid arthritis, psoriastic arthritis, psoriasis, and other inflammatory diseases. While sales have declined, the drug still pulled in over $6.5 billion in sales in 2015.
- A number of other companies are developing biosimilar versions of Remicade. Bioepis' South Korean rival Celltrion beat it to market in the EU however, winning approval in 2013
Samsung Bioepis is aggressively working to develop biosimilars, with 13 candidates in its pipeline including versions of blockbusters like Humira, Lantus, and Avastin. In January, it won approval in the EU for its biosim of Amgen's RA drug Enbrel.
“The CHMP's positive opinion on Flixabi brings us a step closer to broadening affordable, high-quality treatment options for autoimmune patients across Europe,” said Christopher Hansung Ko, Samsung Bioepis CEO.
The recommendation was granted based on a phase 3 study which demonstrated comparable safety and efficacy to Remicade.
Flixabi will now go the European Commission, which will decide on marketing authorization. The EMA recommended it for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
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