FDA Approves Avsola, Remicade Biosimilar, to Treat Active Ankylosing Spondylitis

The U.S. Food and Drug Administration (FDA) has approved Avsola (infliximab-axxq), a biosimilar to Remicade (infliximab), to treat active ankylosing spondylitis, its maker, Amgen, announced.

The new therapy has been approved across all diseases that Remicade can treat, which in addition to active ankylosing spondylitis are moderate-to-severe rheumatoid arthritis, Crohn’s disease, ulcerative colitis, chronic severe plaque psoriasis, and psoriatic arthritis.

A biosimilar is a biological medical product proven to be nearly identical to its reference product, but manufactured by a different company after the original product’s patent expires. Biosimilars are usually sold at significantly lower prices.

Like Janssen Biotech’s Remicade, Amgen’s Avsola is a monoclonal antibody that blocks tumor necrosis factor alpha (TNF)-alpha, an inflammatory molecule with a critical role in inflammation and autoimmune disorders.

The approval was based on data from a Phase 1 trial in healthy volunteers, and a comparative Phase 3 trial in people with moderate to severe rheumatoid arthritis.

In the Phase 1 study (ACTRN12614000903684), 50 healthy participants were randomly assigned to either Avsola (previously ABP 710) or Remicade, both given once daily via intravenous (IV) infusion at a dose of 5 mg/kg. The trial was conducted at two clinical sites in Australia.

Its primary goal was to compare the therapies’ pharmacokinetics — their absorption, distribution, and metabolism in the body, and their excretion — following a single infusion. Additional goals included assessing safety, tolerability, and immunogenicity (the ability to induce an immune response).

Results confirmed that Avsola’s pharmacokinetic profile was similar to that of Remicade, given in its U.S. or EU reference products. Safety and tolerability were also comparable.

Treatment-related adverse events were mild to moderate, and reported in 83.7% of participants given Avsola and in up to 86% of those taking Remicade.

The Phase 3 trial (NCT02937701) randomly assigned 558 patients with moderate-to-severe rheumatoid arthritis to either 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.

Its primary goal was the number of patients achieving a 20% or more decrease in disease activity, according to the American College of Rheumatology criteria (ACR20) at week 22. ACR20 is defined as reduction of 20% in the number of tender and swollen joints, and a 20% improvement/reduction in three of the following: patient global assessment, physician global assessment, functional ability, pain, and inflammation.

Patients who completed 22 weeks of Remicade treatment were then randomly assigned to either continue with that treatment (121 patients) or switch to Avsola (119) until week 46. The 244 patients initially assigned to Avsola continued treatment with the biosimilar until week 46.

The findings, “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,” were presented at the 2019 American College of Rheumatology (ACR)/Association for Rheumatology Professionals (ARP) Annual Meeting, held in Atlanta.

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

“This analysis of ACR individual components further supports the similarity of ABP 710 [Avsola] and infliximab [Remicade],” the researchers wrote.

“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.

“Avsola highlights Amgen’s long-term commitment to providing more affordable biological treatment options to patients across critical disease states, including chronic inflammatory conditions,” he added.

Avsola is the fourth biosimilar of Remicade to be approved in the U.S., following Pfizer‘s Inflectra and Ixifi, and Merck‘s Renflexis.