Avsola Approved as Remicade Biosimilar

December 6, 2019 – The U.S. FDA has approved AvsolaTM (infliximab-axxq), manufactured by Amgen, as a biosimilar for Janssen’s Remicade® (infliximab). It is the fourth Remicade biosimilar to receive FDA approval.

Like Remicade, Avsola is approved to treat certain patients who have rheumatoid arthritis (RA), Crohn's Disease (CD), ulcerative colitis (UC), chronic severe plaque psoriasis (PsO), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). A clinical study found Avsola to have a similar safety and immunogenicity (ability to provoke an immune system response) profile to Remicade.

Recommended dosing depends on the condition being treated. A black box warning cautions that tumor necrosis factor (TNF) blockers like Avsola are associated with a risk of serious infections and malignancies, including fatal hepatosplenic T-cell lymphoma (HSTCL). As a biosimilar, Avsola cannot be automatically interchanged with Remicade or other infliximab products.

However, it may offer a lower-cost alternative for certain patients. Specific pricing and launch information are not yet available.