FDA Approves Avsola, Fourth Remicade Biosimilar
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The FDA has approved the fourth biosimilar to infliximab, infliximab-axxq, for all eligible indications of the biologic product.
Avsola (infliximab-axxq, Amgen), a biosimilar to Remicade (infliximab, Janssen), is a tumor necrosis factor blocker intended for patients with rheumatoid arthritis, in combination with methotrexate, as well as for patients with Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
"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."
With this approval, Avsola has become the fourth biosimilar to Remicade to launch in the United States, following Inflectra (infliximab-dyyb, Celltrion/Pfizer) in 2016, as well as Renflexis (infliximab-abda, Samsung and Merck) and Ixifi (infliximab-qbtx, Pfizer) in 2017.
The FDA based its approval on data from clinical studies that exposed 4,779 adults with RA, Crohn’s disease, ulcerative colitis, AS, PsA, plaque psoriasis or other conditions to infliximab. These included 2,625 patients exposed beyond 30 weeks and 374 exposed beyond 1 year.
Similar to the biologic product, Avsola will include a boxed warning for increased risk for serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections and infections resulting from other opportunistic pathogens.