FDA Approves Infliximab-Axxq as Biosimilar to Infliximab

Officials with the FDA have approved Amgen’s infliximab-axxq (Avsola), a new biosimiliar to infliximab (Remicade).¹ The drug is a tumor necrosis factor (TNF) blocker used to multiple conditions, such as Crohn disease, rheumatoid arthritis, and plaque psoriasis.²

Infliximab-axxq is the 4th biosimilar to infliximab.¹ It is administered as 100 mg of lyophilized infliximab-axxq in a 20 mL single-dose vial for intravenous infusion.²

The drug’s most common adverse reactions (>10%) — infections, including upper respiratory, sinusitis, and pharyngitis; infusion-related reactions, headache, and abdominal pain.²

All FDA-approved biosimilar products meet the FDA’s strict standards for approval. Patients and health care providers can rely on the safety and effectiveness of the biosimilar or interchangeable product just as they would for the reference product, according to the agency.¹

REFERENCES

1. FDA Approves Avsola (infliximab-axxq), 4th biosimilar to Remicade (infliximab) [news release]. Silver Spring, MD; December 6, 2019: FDA [email]. Accessed December 6, 2019.

2. AVSOLA (infliximab-axxq) [Prescribing information]. Thousand Oaks, CA: Amgen; 2019.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761086s000lbl.pdf?utm_campaign=FDA%20Approves%20Avsola%20%28infliximab-axxq%29%2C%204th%20biosimilar%20to%20Remicade%20%28infliximab%29&utm_medium=email&utm_source=Eloqua