Samsung Bioepis, Green Light for European Approval of Stelara Biosimilar

Published 25 Feb.2024 16:21(KST)

Updated 26 Feb.2024 08:28(KST)

Samsung Bioepis announced on the 25th that it has received a positive opinion for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) for Fizzyva (development code SB17), a biosimilar developed as a treatment for autoimmune diseases based on Stelara.

Samsung Bioepis Headquarters Exterior [Photo by Samsung Bioepis]

The European Union (EU) approves new drugs through a process where the CHMP under the EMA, which provides opinions on drug approvals based on scientific evaluation, issues a recommendation for authorization, and the European Commission (EC) grants the final marketing authorization within 2 to 3 months. With this, Fizzyva has cleared a major hurdle for sales within Europe. Last year, Samsung Bioepis signed a partnership agreement with the global pharmaceutical company Sandoz for the sales of Fizzyva in Europe and North America, and accordingly, Sandoz will be responsible for sales in Europe going forward.

The original drug of Fizzyva, Stelara, developed by Johnson & Johnson (J&J), is used to treat autoimmune diseases such as plaque psoriasis, psoriatic arthritis, and Crohn's disease. It is a blockbuster drug that generated sales of $10.858 billion (approximately 14.5 trillion KRW) worldwide last year alone. Autoimmune diseases occur when the immune system mistakenly recognizes normal cells in the body as enemies and attacks them. During this process, interleukins, which are proteins secreted by white blood cells that activate immune cells, play a key role. Stelara treats autoimmune diseases by inhibiting the activity of interleukin-12 and interleukin-23.

Samsung Bioepis currently commercializes a total of seven biosimilar products in the European market, three of which are biosimilars of autoimmune disease treatments similar to Stelara: Enbrel, Remicade, and Humira. These biosimilars work by inhibiting tumor necrosis factor (TNF)-alpha (α) to treat autoimmune diseases. With the positive opinion for Fizzyva’s approval, Samsung Bioepis can further expand its portfolio of autoimmune disease treatments.

Johnson & Johnson's autoimmune disease treatment Stelara (active ingredient 'Ustekinumab')

Jung Byung-in, Head of Regulatory Affairs (RA) Team at Samsung Bioepis (Executive Director), said, "We are pleased to receive the European approval recommendation for Fizzyva, Samsung Bioepis’s first interleukin-inhibiting drug," adding, "We will continue to strive to provide more treatment options to patients by securing a diverse pipeline."