FDA Approves Amgen’s Infliximab-axxq

The FDA has approved infliximab-axxq (Avsola, Amgen Inc), biosimilar to Janssen’s Remicade, for the treatment of Chrohn’s disease in adults and pediatric patients, ulcerative colitis, rheumatoid arthritis in combination with methotrexate, and psoriatic arthritis. 

Infliximab-axxq is an anti-tumor necrosis factor (anti-TNF) alpha monoclonal antibody with the same amino acid sequence as Remicade, according to prescribing information. 

Approval for infliximab-axxq is based upon the results of a randomized, double-blind, comparative clinical study that evaluated the safety and efficacy of infliximab-axxq (formerly ABP 710) to Remicade. 

The study included 558 participants, with a primary end point of the response difference (RD) of 20% improvement in the American College of Rheumatology’s core set measurements at week 22. Secondary end points included DAS-28-CRP change from baseline; and RD of ACR20, ACR50 and ACR70 at weeks 2, 6, 14, 22, 30, 34, 38, 46, and 50.

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According to Amgen’s official release, the study also included a single transition in 119 subjects from Remicade to infliximab-axxq. 

"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 in a statement. "Following July's exciting launches of our 2 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." 

Prescribing information for infliximab-axxq includes a boxed warning highlighting: 

• increased risk of serious infections that could lead to hospitalizations including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens

• development of lymphoma and other malignancies, some fata, in children and adolescent patients treated with TNF blockers and infliximab products

• postmarketing instances of fatal hepatosplenic t-cell lymphoma 

Infliximab-axxq is contraindicated in dosages exceeding 5 mg/kg in patients with moderate to severe heart failure, and for patients with previous hypersensitivity reactons to infliximab products or known hypersensitivity to inactive components of infliximab-axxq and/or murine products. 

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Other warnings and precautions for infliximab-axxq include serious infections, invasive fungal infections, malignancies, hepatitis B virus reactivation, hepatotoxicity, heart failure, cytopenias, hypersensitivity, cardiovascular and cerebrovascular reactions, demyleinating disease, lupus-like syndrome. Infliximab-axxq should not be given with live vaccines or therapeutic infectious agents. 

Adverse reactions reported with the use of infliximab-axxq include infections (e.g., upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.

Full Prescribing Information