FDA Approves Inflectra, a Biosimilar to Remicade
April 5, 2016 – The FDA approved Inflectra™ (infliximab-dyyb) manufactured by Pfizer and Celltrion. Inflectra is a biosimilar to Janssen’s Remicade and is indicated for treating patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and adult and pediatric Crohn’s disease. These are all of the same indications as Remicade except pediatric ulcerative colitis.
While Inflectra is biosimilar to Remicade, it is not considered a generic medication and cannot be considered interchangeable with Remicade without approval from a physician. This is the second biosimilar to be approved by the FDA.
The dose of Inflectra varies depending on the indication. Pfizer plans on launching Inflectra in 2016; however, litigation possibly could delay the launch.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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 1-800-332-0178
Actual drug patent expiration dates and a 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.