Biogen’s new biosimilar Imraldi earns recommendation for EU approval

Biogen has announced that its new biosimilar anti-TNF therapy Imraldi has been recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion endorsing the use of the adalimumab biosimilar in the same indications as its reference product Humira. 

If approved, it would be used in the treatment of rheumatoid arthritis, axial spondyloarthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, polyarticular juvenile idiopathic arthritis, active enthesitis-related arthritis, hidradenitis suppurativa and non-infectious uveitis.

Clinical trials have shown that Imraldi can provide equivalent efficacy and comparable safety and immunogenicity to Humira, but at a lower cost.

This marks the third anti-TNF candidate to be submitted for European Medicines Agency approval by Samsung Bioepis, a joint venture established by Samsung BioLogics and Biogen.

Dr Alpna Seth, senior vice-president and global head of the biosimilars business unit at Biogen, said: "Being able to provide this range of anti-TNF treatment alternatives bolsters our leadership position and underscores our commitment to expanding physician choice, while supporting the sustainability of healthcare systems."

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