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December 10, 2018

US FDA accepts Samsung Bioepis’ application for Humira biosimilar

PUBLISHED : September 27, 2018 - 15:48

UPDATED : September 27, 2018 - 16:00

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[THE INVESTOR] Samsung Bioepis said on Sept. 27 that the US Food and Drug Administration has accepted its application to review SB5, its biosimilar candidate referencing US drug maker AbbVie’s Humira, the biggest-selling drug in the world.

With SB5, the biopharmaceutical company has four biosimilar products approved or put under review by the US health regulator including its versions of Johnson & Johnson’s Remicade, Roche’s Herceptin and Sanofi’s Lantus. 



Humira, the world’s top-selling treatment with revenue of US$16 billion last year, is an anti-tumor necrosis factor monoclonal antibody that currently treats Crohn’s disease, rheumatoid arthritis, ulcerative colitis, hidradenitis suppurativa, psoriasis and others.

Samsung Bioepis, which has already received marketing authorization in Europe, Korea, Australia and Canada for SB5, is seeking to take away Humira’s market share in the US, where AbbVie raked in over 60 percent of its total revenue of the anti-TNF drug. The US pharmaceutical firm’s exclusivity for Humira will lapse in 2020 in the US.

The Biologics License Application for SB5 was based on data derived from phase 3 study, in which 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy were randomized to receive either SB5 or the original product Humira.

At Week 24, the ACR20 response rate was 72.4 percent in the SB5 group versus 72.2 percent in the Humira group. The safety profile of SB5 was comparable to Humira up to Week 24, when 254 patients receiving Humira were re-randomized in a 1:1 ratio to continue on Humira or transitioned to SB5, and 254 patients receiving SB5 continued to receive SB5.

“Up to Week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by alternating subjects between treatments,” Samsung Bioepis said.

By Park Han-na (hnpark@heraldcorp.com)

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