The FDA has approved the biosimilar Inflectra (infliximab-dyyb) for multiple indications.
Infectra is a biosimilar to Remicade (infliximab), and can be prescribed by a clinician for treatment of the following conditions:
- Adult and pediatric patients with moderate to severe Crohn’s disease, who have had inadequate response to conventional therapy
- Adult patients with moderate to severe ulcerative colitis, who have had an inadequate response to conventional therapy
- Patients with moderate to severe rheumatoid arthritis, in combination with methotrexate
- Patients with ankylosing spondylitis
- Patients with active psoriatic arthritis
- Adult patients with chronic, severe plaque psoriasis.
The FDA’s approval of Inflectra was based on an evidence review that included data from animal studies, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and clinical safety and effective data. Inflectra has been approved as a biosimilar, and not as an interchangeable drug.
“Biosimilars can provide access to important treatment options for patients who need them. Patients and the healthcare community can be confident that biosimilar products are high quality and meet the agency’s rigorous scientific standards,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
Inflectra is administered via intravenous infusion. Common side effects of Inflectra include respiratory infections including sinus infections and sore throat, headache, coughing, and stomach pain, as well as infusion reactions up to 2 hours after an infusion. Infusion reaction symptoms include fever, chills, chest pain, low or high blood pressure, shortness of breath, rash, and itching.
Inflectra includes a boxed warning alert about an increased risk of serious infection, including tuberculosis and bacterial sepsis, as well as liver injury, blood problems, psoriasis, and nervous system disorders.
- FDA approves Inflectra, a biosimilar to Remicade [news release]. Silver Spring, MD: US Food and Drug Administration. Published April 5, 2016. Accessed April 13, 2016.