Samsung Bioepis Receives First FDA Drug Approval for Remicade Biosimilar

South Korea-based biopharmaceutical company, Samsung Bioepsis, has received its first product approval for the US market. The company’s biosimilar of Johnson & Johnson’s Remicade (infliximab) was approved for all eligible indications.

Samsung Bioepsis’ Renflexis (infliximab-abda) has been approved by the FDA to treat rheumatoid arthritis and Chrohn’s disease, along with other autoimmune diseases. The drug is the second biosimilar version of Remicade to be approved by the regulator, potentially threatening Johnson & Johnson’s $7 billion in annual sales for the biologic.

“Since our company was established five years ago, we have strived day in and day out to realize the promise of biosimilars for patients across the United States by offering them treatment options at a lower cost. We hope this regulatory milestone will bring us a step closer to achieving this goal,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “Through relentless process innovation and an uncompromising commitment to quality, we remain committed to advancing one of the industry’s strongest biosimilar pipelines.”

Remicade can cost over $30,000 per year for an adult patient without insurance coverage. While it’s unclear exactly how Renflexis will be priced, it’s likely that it will be less expensive compared to the reference biologic.

Renflexis is an injectable biologic which blocks the action of a cell signaling protein known as tumor necrosis factor (TNF). The biosimilar does contain the same FDA-mandated boxed warning as its reference biologic, which warns doctors and patients of an increased risk of serious infections, such as tuberculosis, which could be fatal.

Renflexis has already been approved in 28 EU member states under the trade name Flixabi, along with a few countries in the Asia-Pacific. The biosimilar will be marketed and distributed in the US by Samsung’s partner, Merck.

Last year, Pfizer and Celltrion’s Inflectra became the first biosimilar of Remicade to be approved in the US.  Samsung Bioepsis expects that Renflexis will be available in the US in the next six months.