Pfizer Inc. will begin shipment of INFLECTRA® (infliximab-dyyb)for injection, a biosimilar of REMICADE® (infliximab) to wholesalers in the United States (U.S.) in late November 2016.
INFLECTRA will be the first biosimilar monoclonal antibody (mAb) and only the second biosimilar to be available in the U.S.
It is approved for the treatment of:
- adult patients and pediatric patients (ages six years and older) with moderate to severely active Crohn’s disease who have had an inadequate response to conventional therapy;
- adult patients with moderate to severely active ulcerative colitis who have had an inadequate response to conventional therapy; and
- moderate to severely active rheumatoid arthritis in combination with methotrexate; active ankylosing spondylitis; active psoriatic arthritis; and chronic severe plaque psoriasis.
Pfizer holds exclusive commercialization rights to Celltrion’s INFLECTRA in the U.S., and has already successfully introduced INFLECTRA in other markets across the globe.
INFLECTRA will be introduced at a 15% discount to the current wholesaler acquisition cost (WAC) of REMICADE®, its reference product. WAC is not inclusive of discounts to payers, providers, distributors and other purchasing organizations.