Inflectra to Launch in Late November
October 17, 2016 – Pfizer announced that it will launch Inflectra™ (infliximab-dyyb) in late November. Inflectra is a biosimilar to Remicade®, manufactured by Jansen, was approved on April. 5, 2016, for all Remicade-approved indications, except pediatric ulcerative colitis. It will be used for treating patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and adult and pediatric Crohn’s disease. Inflectra, a tumor-necrosis factor (TNF) blocker, was the first biosimilar monoclonal antibody to gain FDA approval. Based on the wholesale acquisition cost (WAC), Inflectra will be priced at a 15% discount to Remicade.
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-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.