Infliximab Biosimilar Gets FDA Approval

The Food and Drug Administration (FDA) has approved Avsola (infliximab-axxq; Amgen), a biosimilar to Remicade (infliximab; Janssen Biotech).

Avsola, a tumor necrosis factor (TNF) blocker, is indicated for:

• Crohn disease (CD): reducing signs/symptoms, inducing and maintaining clinical remission for moderately to severely active CD in adult and pediatric patients with inadequate response to conventional therapy; reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adults with fistulizing disease. 

• Ulcerative colitis (UC): reducing signs/symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active UC who have had an inadequate response to conventional therapy.
• Pediatric UC: reducing signs/symptoms, inducing and maintaining clinical remission for moderately to severely active UC in pediatric patients aged ≥6 years old who have had an inadequate response to conventional therapy.  
• Rheumatoid arthritis (RA): in combination with methotrexate to reduce signs/symptoms, inhibit the progression of structural damage, and improve physical function in patients with moderately to severely active RA.
• Ankylosing spondylitis (AS): reducing signs/symptoms in patients with active AS.
• Psoriatic arthritis (PsA): reducing signs/symptoms, inhibiting the progression of structural damage, and improving physical function in patients with active PsA.
• Plaque psoriasis (PsO): treating adult patients with chronic severe (ie, extensive and/or disabling) PsO who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

The approval of Avsola was based on data demonstrating that it is highly similar to Remicade with no clinically meaningful differences based on evidence which included comparative analytical, nonclinical and clinical data. The data included results from a pharmacokinetic (PK) similarity study conducted in healthy subjects, and a comparative clinical study conducted in patients with moderate to severe RA.

“The approval of Avsola represents an important milestone across our biosimilar and inflammation portfolios,” said Murdo Gordon, executive VP of Global Commercial Operations at Amgen. “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.”

Avsola will be supplied in 100mg single-dose vials.

For more information visit amgen.com.

This article originally appeared on MPR