EU clears Samsung Bioepis, Biogen's Remicade biosimilar Flixabi

Samsung Bioepis and partner Biogen said Monday that the European Commission approved Flixabi, a biosimilar version of Johnson & Johnson and Merck & Co.'s Remicade (infliximab), for the treatment of rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. The decision follows a positive opinion adopted for Flixabi, also known as SB2, by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in April.

Approval was supported by early- and late-stage data, including results from a 54-week Phase III trial of 584 patients with moderate-to-severe RA despite methotrexate therapy. Patients in the study were randomised to receive Flixabi or Remicade, with the primary endpoint being a response at week 30 of at least a 20-percent improvement in RA symptoms based on American College of Rheumatology criteria (ACR20) in the pre-protocol set (PPS).

Results showed that the study met its primary endpoint, with the Flixabi and Remicade arms achieving ACR20 response rates of 64.1 percent and 66 percent, respectively. At 54 weeks, the ACR20 response rate in the PPS was 65.3 percent for Flixabi-treated patients, versus 69.2 percent in the Remicade group. According to Biogen, ACR20 response in the full analysis set at both time points also showed equivalence between Flixabi and Remicade, with respective rates of 55.5 percent and 59 percent at week 30, and rates of 50.7 percent and 52.6 percent at week 54. Moreover, the companies said Flixabi was well tolerated and had comparable safety to Remicade.

Biogen indicated that it will be responsible for the commercialisation and distribution of the drug in Europe. Alpna Seth, global head of the company's biosimilars unit, noted the approval of Flixabi makes Biogen "the first company to bring two anti-TNF biosimilars to patients and physicians across Europe." In January, Samsung Bioepis received EU approval for Benepali, also known as SB4, a biosimilar referencing Amgen's Enbrel (etanercept), which has since been launched by Biogen in several EU countries.

Earlier this month, Samsung Bioepis announced that the FDA has accepted to review its filing seeking approval of SB2 for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. In April, the FDA cleared Celltrion's Remicade biosimilar Inflectra (infliximab-dyyb), which will be marketed in the US by Pfizer for the treatment of multiple indications, including RA. Celltrion developed Inflectra under a 2009 agreement with Hospira, with Pfizer obtaining rights to the therapy following its acquisition of Hospira last year.

For related analysis about the US biosimilars market, see KOL Views: Is it a question of 'when' rather than 'if' there is a biosimilars explosion in the US market? and Biosimilars: US Payer Perspectives.

Hospira also announced last year that it had launched Inflectra as a biosimilar version of Remicade in various European markets, as had Celltrion under the brand name Remsima. Earlier this year, Pfizer divested the European development and marketing rights to its proposed Remicade biosimilar, dubbed PF-06438179, to Novartis' Sandoz unit in order to satisfy EU antitrust concerns in the lead-up to its Hospira takeover.


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