Samsung Bioepis gets approval for Stelara biosimilar in Europe

[Courtesy of Samsung Bioepis Co.]

Samsung Bioepis Co., a biopharmaceutical research and development unit under South Korea’s Samsung Group, has obtained approval for Pyzchiva, a biosimilar version of Stelara, from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), the company said on Tuesday.

Pyzchiva marks Samsung Bioepis’ fourth autoimmune disease treatment developed, following Benepali, Flixabi, and Imraldi.

The final approval for Pyzchiva comes just two months after receiving a positive opinion for the product from the CHMP in February.

Stelara, developed by Janssen, is prescribed for conditions such as plaque psoriasis, psoriatic arthritis, and ulcerative colitis, and works by inhibiting the activity of interleukin (IL)-12 and IL-23, which are types of inflammatory cytokines associated with immune responses.

According to market data from last year, Stelara generated global sales of about $10 billion. The sales of Pyzchiva in Europe will be led by Sandoz. A sales partnership agreement for the European and North American market was signed in September last year.

In Korea, Pyzchiva became the first Stelara biosimilar to receive approval from the Ministry of Food and Drug Safety on April 11.