Celltrion’s adalimumab biosimilar, Yuflyma (CT-P17) has been approved by the European Commission for the treatment of multiple chronic inflammatory diseases, including rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis.
This month marks a major US milestone for biosimilar medicines as five years ago, September 2015, saw the first biosimilar made available to US patients – the Sandoz developed Zarxio (filgrastim-sndz).
Imraldi becomes the second version of AbbVie’s best-selling biologic Humira (adalimumab) to be approved and the fourth biosimilar success for Samsung Bioepis in Europe.
The EMA has recommended the approval of Samsung Bioepis’ adalimumab biosimilar, placing the firm on the brink of having three anti-TNF inhibitors in Europe.
A clear interchangeability pathway is essential for the US biosimilar market say developers as they begin reviewing the much-welcomed draft FDA guidance.
Having a proactive approach to delivery technologies will give pharma firms a competitive edge against biosimilars and biobetters, according to device maker Bespak.
A copycat version of Amgen’s Enbrel has been approved in Korea, marking the first regulatory success for Merck & Co and Samsung Bioepis' biosimilar joint venture.
