Ixifi Approved as Biosimilar for Remicade
December 13, 2017 – The U.S. FDA has approved Ixifi™ (infliximab-qbtx), manufactured by Pfizer, as a biosimilar for Janssen’s Remicade® (infliximab). The new biosimilar’s approved indications include the treatment of plaque psoriasis, Crohn’s disease, rheumatoid arthritis, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis.
Pfizer has announced that it does not currently have plans to launch Ixifi in the United States, in spite of the drug’s FDA approval. The company already has a Remicade biosimilar on the market, Inflectra® (infliximab-dyyb), on which Pfizer has stated it intends to focus its commercial efforts. An additional biosimilar to Remicade, Merck’s Renflexis™ (infliximab-abda), is also available in the U.S.
Like other tumor necrosis factor (TNF) inhibitors, Ixifi carries a black box warning that it can increase the risk of serious infection, including tuberculosis, and that drugs of this type have been linked to lymphoma and other cancers in children and adolescents. Recommended dosing with Ixifi is based on the indication. As with other biosimilars, Ixifi is not automatically interchangeable with its reference product.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.