Second Biosimilar for Remicade Launched
July 24, 2017 – Merck and Samsung Bioepis have released Renflexis™ (infliximab-abda) in the United States. The launch comes three months after the drug was granted U.S. FDA approval on April 21, 2017. A tumor necrosis factor (TNF) inhibitor, Renflexis is a biosimilar for Janssen Biotech’s Remicade® (infliximab). It is indicated for the treatment of ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis (RA), Crohn’s disease in both adults and children, and ulcerative colitis.
Dosing recommendations for Renflexis vary by indication. Like other infliximab drugs, it includes a medication guide and black box warning that it may cause lymphomas or other cancers among children and teens, as well as serious infections in patients of any age.
Renflexis is the second biosimilar to Remicade to be launched in the U.S. The first, Pfizer and Celltrion‘s Inflectra® (infliximab-dyyb), entered the market in November of 2016. The anticipated list price for Renflexis is $750 per 100mg vial, which is approximately $420 less per vial than Remicade, and $200 less than Inflectra. Johnson & Johnson, Janssen’s parent company, reports that 2016 U.S. sales of Remicade totaled approximately $5 billion.
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.