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Second Remicade biosimilar given green light in Europe

Samsung Bioepis’ Flixabi provides another lower-cost treatment option
European Commission

Samsung Bioepis has been given EU approval for Flixabi, their biosimilar version of Johnson & Johnson's immunology blockbuster Remicade.

Like Remicade (infliximab), the biosimilar can be used to treat rheumatoid arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, psoriasis and psoriatic arthritis, and will provide another lower-cost option when it launches later in the year.

Flixabi is the second biosimilar of the drug to be approved in the EU after Hospira and Celltrion's version, sold respectively as Inflectra and Remsima, which reached the market last year.

It has been developed by Samsung Bioepis - a joint venture between Samsung BioLogics and Biogen - and will be sold by Biogen in the EU.

A third Remicade biosimilar (PF-06438179) is in phase III testing and could be on the EU market next year. Originally developed by Pfizer, it was divested to Sandoz as an antitrust condition of Pfizer's takeover of Hospira.

Flixabi has been approved on the back of a 54-week phase III trial which showed the drug was equivalent to Remicade in achieving a 20% improvement in symptoms (ACR 20 response) in patients with moderate-to-severe rheumatoid arthritis not fully controlled with methotrexate. The biosimilar has also been submitted for approval in the US.

J&J reported $1.3bn in ex-US sales for TNF inhibitor Remicade last year, a decline of 19% thanks to increased competition in its approved indications, both from biosimilars and new branded therapies. Worldwide sales of the drug were $6.56bn in 2015, down 4%.

J&J said last month it does not anticipate biosimilar competition in the US to kick in until 2017, although Celltrion has suggested it will launch there by the end of the third quarter.

This is the second EU approval for Samsung Bioepis after it got the go-ahead to sell its biosimilar version of Pfizer/Amgen's TNF blocker Enbrel (etanercept) in January. All told, anti-TNF inhibitors make up an estimated $10bn market in the EU, according to GlobalData figures.

The biosimilar, called Benepali, has already been launched in several EU markets including the UK, Germany, Denmark, Norway, Sweden, and The Netherlands.

Article by
Phil Taylor

31st May 2016

From: Regulatory

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