Amgen gets FDA nod for biosimilar Remicade
Amgen has received the Food and Drug Administration’s approval for Avsola (infliximab-axxq) for all approved indications of Janssen’s Remicade (infliximab.
Avsola has been approved to treat moderate-to-severe rheumatoid arthritis, moderate-to-severe Crohn's disease in the adult and pediatric population, moderate-to-severe ulcerative colitis in the adult and pediatric population, chronic severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.
"The approval of Avsola represents an important milestone across our biosimilar and inflammation portfolios," said Murdo Gordon, executive vice president 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."