Amgen’s Infliximab Biosimilar, Avasola, Receives FDA Approval

On December 6, 2019, the US Food and Drug Administration (FDA) gave Amgen its approval to market the fourth biosimilar infliximab medicine.

Dubbed Avasola (infliximab-axxq), a launch date was not announced, but one can assume that Amgen intends to launch this agent as soon as possible. This infliximab biosimilar was approved for all of the autoimmune indications of the reference product Remicade®.

Avasola will be the third infliximab biosimilar agent to be marketed, as Pfizer’s Ixifi®, though approved, is not sold in the US, as it would compete directly with another Pfizer-marketed biosimilar (Inflectra®). Pricing for the Avasola was not yet available.

Avasola was approved based on clinical studies involving patients with inflammatory bowel disease, rheumatoid arthritis, and other indicated conditions (over 4,800 patients taking the drug), including a phase 3 investigation pitting the biosimilar against the reference product in patients with rheumatoid arthritis.

The US market for infliximab is shrinking somewhat, based on falling sales numbers caused by biosimilar competition and prescriptions lost to other biologics. According to Johnson & Johnson, parent of Remicade’s manufacturer (Janssen Biotech), US revenues shrank 24% (to $1.14 billion) in the third quarter of 2019 compared with the same quarter of 2018.

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