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.

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 or Remicade at a dose of 3 mg/kg, administered on day one and at weeks two and six, and then every eight weeks for 22 weeks.

The study’s primary goal was to assess the percentage of patients achieving a minimum 20% reduction in disease activity, according to the American College of Rheumatology criteria (ACR20) at week 22.

Additional (secondary) goals included assessing the percentage of patients achieving a minimum of 50% and 70% reduction in disease activity (ACR50 and ACR70) before and after week 22, as well as changes in the Disease Activity Score 28 (DAS28) through and after week 22.

After completing 22 weeks of treatment with Remicade, 121 participants were randomly assigned to continue treatment, and 119 switched over to Avsola until week 46. Those who had been originally assigned to Avsola continued treatment with the biosimilar until week 46.

Results showed similar responses to Avsola and Remicade. Safety and immunogenicity with continued treatment with Avsola were similar to those seen in people previously on Remicade.

The findings were presented in a poster session, titled “Efficacy of Biosimilar Candidate ABP 710 in a Phase 3 Study in Subjects with Moderate to Severe RA: Additional Analysis Focusing on the ACR Individual Components,” at the  2019 American College of Rheumatology/Association for Rheumatology Professionals Annual Meeting, held in Atlanta.

“The approval of Avsola represents an important milestone across our biosimilar and inflammation portfolios,” Murdo Gordon, executive vice president of Global Commercial Operations at Amgen, said in a press release.

“Following July’s exciting launches of our two biosimilars in oncology, Avsola highlights Amgen’s long-term commitment to providing more affordable biological treatment options to patients across critical disease states, including chronic inflammatory conditions,” Gordon said. 

Avsola is the fourth biosimilar of Remicade to be approved in the U.S., following Pfizer‘s Inflectra and Ixifi, and Merck‘s Renflexis. It is also the fourth biosimilar developed by Amgen to be approved in the U.S. The company currently has 10 biosimilars in its portfolio, three of which have already been approved in the E.U.