The European Commission has actually authorized Celltrion Health care’s Yuflyma, a biosimilar to adalimumab– marketed by AbbVie as Humira.
The EC has actually given the marketing authorisation for Yuflyma throughout all 13 indicators for the treatment of a series of persistent inflammatory illness, consisting of rheumatoid arthritis, ulcerative colitis and psoriasis.
The marketing authorisation is based upon analytical, preclinical and medical research studies which showed that Yuflyma is equivalent to the recommendation item adalimumab, consisting of in regards to effectiveness and security.
Yuflyma is the very first adalimumab biosimilar authorized in the EU with a high concentration, low-volume and citrate-free solution, Celltrion stated in a declaration.
” With high concentration, low-volume, and as a result less discomfort, adalimumab can enhance treatment adherence at least. For that reason, we concentrated on advancement of a high concentration biosimilar to supply a substantial option to the adalimumab treatment classification,” stated Dr. HoUng Kim, head of medical and marketing department at Celltrion Health care.
” In regards to the administration gadget, we have actually aimed to make sure enhanced benefit for clients in addition to service providers with the addition of needle size (29G), latex-free to decrease allergic reaction threat, and a long storage duration or service life at space temperature level for 1 month,” he included.