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Biz News Korea(Eng)
Samsung Bioepis gets positive CHMP opinion for its second biosimilar
- Collected
- 2016.04.05
- Distributed
- 2016.04.06
- Source
- Go Direct
The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the marketing authorization of Flixabi (infliximab), an infliximab biosimilar candidate referencing Remicade, Samsung Bioepis said on Sunday.
The positive opinion will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union (EU). The European Medicines Agency’s (EMA) recommendation leads to approval by the EC in two to three months, and then Flixabi could be prescribed in the same indications as Remicade in 31 European countries.
The positive CHMP opinion comes shortly after marketing authorization was granted for Benapali (etanercept), a biosimilar referencing Enbrel, last January.
Flixabi’s reference drug is Janssen’s Remicade to treat rheumatoid arthritis and ulcerative colitis among others.
In Korea, the drug was approved by the Ministry of Food and Drug Safety last December under the brand name of Renflexis. Samsung Bioepis emphasized Flixabi was proven equivalent to the original drug in efficacy and safety in Phase 3 clinical trials in 11 countries.
“Flixabi will help reduce healthcare costs in European countries and more patients with auto-immune disorders will have access to preion of drugs with excellent efficacy,” said Samsung Bioepis CEO and President Ko Han-sung.
Samsung Bioepis is developing biosimilar versions of three major biologics to treat autoimmune diseases: Enbrel, Remicade and Humira.
By Kim Gi-chul
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