Biogen and Samsung Bioepis’ new biosimilar accepted for European review

Biogen has announced that SB5, an adalimumab biosimilar candidate referencing Humira, has been accepted for European regulatory review.

The European Medicines Agency will be assessing the performance of the new biosimilar in all of the same indications for which Humira is approved, including rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.

SB5 was developed by Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen. This is the third of its anti-TNF biosimilar candidates to be submitted for EU approval, following filings for biosimilar versions of Enbrel and Remicade earlier this year.

Data from two head-to-head studies have shown that SB5 can offer comparable efficacy, safety and immunogenicity to Humira, and will be used to support this application.

Dr Alpna Seth, senior vice-president and global head of the biosimilars business unit at Biogen, said: "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."

If approved, it is hoped that SB5 could offer a more affordable alternative to Humira, one of the world's most widely-prescribed drugs.