FDA Approves Avsola, Remicade Biosimilar, to Treat Crohn’s Disease and Ulcerative Colitis

FDA Approves Avsola, Remicade Biosimilar, to Treat Crohn’s Disease and Ulcerative Colitis
The U.S. Food and Drug Administration (FDA) has approved Amgen’s Avsola (infliximab-axxq) — a biosimilar to Janssen’s Remicade (infliximab) — to treat adults and children with moderate-to-severe Crohn’s disease (CD) and ulcerative colitis (UC). The biosimilar therapy has been approved for all diseases that Remicade is approved to treat, which also includes moderate-to-severe rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. A biosimilar has similar active properties, as well as comparable safety and efficacy, to an original brand medication. Similar to generics, they are predicted to cost less than the reference therapies, depending on country and insurance plan. Companies may start producing biosimilars when the patent of the original brand product expires, after obtaining a license from its manufacturer. Like Remicade, Avsola is a monoclonal antibody that blocks a pro-inflammatory molecule called tumor necrosis factor (TNF)-alpha, which is produced in excess in different types of autoimmune diseases. The decision to approve Avsola for the same indications as Remicade's was partly based on data from a pharmacokinetic study (ACTRN12614000903684) that demonstrated its similarity to the reference brand product in healthy volunteers, and on a comparative Phase 3 trial in a group of patients with moderate-to-severe RA. (Pharmacokinetics is the study of how a medication is absorbed, distributed, metabolized, and eliminated from the body). The randomized, double-blind, Phase 3 trial (NCT02937701) compared the safety and efficacy of Avsola (formerly called ABP710) to Remicade in a group of 558 people with moderate-to-severe RA. All participants were randomly assigned to receive intravenous infusions of Avsola
Subscribe or to access all post and page content.