Renflexis, Biosimilar for Remicade to Treat Crohn’s and UC, Approved by FDA

Renflexis, Biosimilar for Remicade to Treat Crohn’s and UC, Approved by FDA

Renflexis (infliximab-abda), a biosimilar of Remicade (infliximab), has been approved in the U.S. to treat a number of autoimmune diseases, including adult and pediatric Crohn’s disease and adult ulcerative colitis.

Samsung Bioepis, which manufactures Renflexis, announced the U.S. Food and Drug Administration’s approval notice in a recent press release. The treatment was approved for use in Europe and Australia last year.

Renflexis is the first  biosimilar (cheaper biological medicines almost identical to original brand-name products) by the company to receive FDA approval. In addition to Crohn’s and ulcerative colitis, it now may be used to treat people with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

Renflexis and Remicade are biological medicines, that is, drugs designed using biological substances. They are synthetically produced parts of antibodies, the same proteins that fight bacteria and viruses after vaccination. Renflexis and Remicade work against tumor necrosis factor alpha (TNF-α), a naturally occurring substance that is produced at high levels in people with some autoimmune diseases, in which the body’s own immune system causes injury to tissues and organs.

Samsung Bioepis is based in South Korea and is developing a series of biosimilar candidates. Its initial six biosimilar candidates are focused on immunology, oncology and metabolic diseases.

Renflexis will be marketed and distributed in the U.S. by Merck, which is known as MSD outside of the U.S. and Canada.

“Merck is committed to delivering on the promise of biosimilars and we look forward to bringing Renflexis forward to help meet the needs of physicians, patients and healthcare systems,” Dora Bibila, general manager, Merck Biosimilars, said in a 2015 press release, when the biosimilar was approved for use in Korea.

“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. “[W]e remain committed to advancing one of the industry’s strongest biosimilar pipelines.”

Biosimilars are drugs whose design is based on that of original biological medicines, and are almost identical in structure and activity. They are officially approved versions of original products, and can be produced when the original product’s patent expires.