EU authorises Celltrion’s adalimumab biosimilar Yuflyma

The European Commission has approved Celltrion Healthcare’s Yuflyma, a biosimilar to adalimumab – marketed by AbbVie as Humira.

The EC has granted the marketing authorisation for Yuflyma across all 13 indications for the treatment of a range of chronic inflammatory diseases, including rheumatoid arthritis, ulcerative colitis and psoriasis.

The marketing authorisation is based on analytical, preclinical and clinical studies which demonstrated that Yuflyma is comparable to the reference product adalimumab, including in terms of efficacy and safety.

Yuflyma is the first adalimumab biosimilar approved in the EU with a high concentration, low-volume and citrate-free formulation, Celltrion said in a statement.

“With high concentration, low-volume, and consequently less pain, adalimumab can improve treatment adherence at the very least. Therefore, we focused on development of a high concentration biosimilar to provide a significant alternative to the adalimumab treatment category,” said Dr. HoUng Kim, head of medical and marketing division at Celltrion Healthcare.

“In terms of the administration device, we have looked to ensure improved convenience for patients as well as providers with the inclusion of needle size (29G), latex-free to reduce allergy risk, and a long storage period or shelf life at room temperature for 30 days,” he added.