Inflectra is indicated to treat patients with various severe autoimmune diseases such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
The FDA approval was based on the data package submitted by Celltrion which demonstrated a high degree of similarity between Inflectra and Remicade.
Respiratory infections inclusing sinus infections and sore throat, headache, coughing and stomach pain are the most common expected side effects of Inflectra.
Inflectra is the second biosimilar approved for sale in the US. Last year, the FDA approved Sandoz’s Zarzio, a biosimilar of Amgen’s ($AMGN) Neupogen cancer drug.
Pfizer holds exclusive commercialization rights to Inflectra in the US and several other jurisdictions. The company said it is continuing with the preparation of its launch plans for 2016, but the timing will depend on several factors like marketplace dynamics and intellectual property considerations.
FDA center for drug evaluation and research director Janet Woodcock said: "Biosimilars can provide access to important treatment options for patients who need them.
"Patients and the health care community can be confident that biosimilar products are high quality and meet the agency’s rigorous scientific standards."
Inflectra is currently approved in 71 countries globally including Canada, Japan and across Europe.
Image: Inflectra is administered by intravenous infusion. Photo: courtesy of hin255/FreeDigitalPhotos.net.