European Medicines Agency reviews marketing authorization application for adalimumab biosimilar

Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen, announced the European Medicines Agency has accepted for review the marketing authorization application for SB5, an adalimumab biosimilar candidate referencing AbbVie’s Humira.

The clinical data on SB5 demonstrated pharmacokinetic bioequivalence to Humira in a phase 1 study and demonstrated comparable efficacy, safety and immunogenicity to Humira in a phase 3 study in patients with rheumatoid arthritis (RA), according to a company press release.

“The submission of SB5 by Samsung Bioepis reflects the joint goal of the partners to take the lead in expanding access to high-quality biologic therapies for those living with chronic inflammatory disorders,” Alpna Seth, PhD, senior vice president and global head of the Biosimilars Business Unit at Biogen, said in the release. “At an estimated $4 billion a year, Humira is among the [European Union’s] EU’s largest single drug expenditures, but access still remains variable in many markets. If SB5 is approved, we will have the potential to make a substantial impact by bridging this access gap for patients while supporting the sustainability of health care systems.”

Alpna Seth

The release noted Humira is approved in the European Union for use in patients with moderate to severe rheumatoid arthritis, ankylosing spondylitis, moderate to severe plaque psoriasis, active and progressive psoriatic arthritis, moderate to severely active Crohn’s disease and moderate to severely active ulcerative colitis.

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