Top-line results from interchangeability study of Humira biosimilar SB5

3 August 2023

South Korea’s Samsung Bioepis and USA-based Organon (NYSE: OGN) have announced the interchangeable result of its Humira (adalimumab) biosimilar, SB5, based on a recently conducted Phase IV study.

The Phase IV, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study (NCT05510063) for SB5 was conducted across 33 sites in four countries (Bulgaria, Czechia, Lithuania, Poland) from August 2022 to May 2023 in patients with moderate to severe chronic plaque psoriasis.

There are currently nine approved biosimilar agents referencing AbbVie’s (NYSE: ABBV) blockbuster biologic Humira available in the USA, and a rapidly overcrowded market is emerging. Evidence and approval of interchangeability could be an important factor to gaining market share.

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