Pfizer will begin shipment of INFLECTRA (infliximab-dyyb) for injection, a biosimilar of REMICADE 1 (infliximab) to wholesalers in the United States (U.S.) in late November 2016.
As Pfizer’s Monday press release reads, 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.
“Biologics have revolutionized the treatment of many life-threatening and chronic diseases. By introducing INFLECTRA to the U.S. marketplace, Pfizer is helping customers access an additional high quality treatment option that promises greater savings for the healthcare system,” said Diem Nguyen, regional president North America, Pfizer Essential Health Business.
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, the company has noted.
Pfizer has also said that INFLECTRA will be introduced at a 15% discount to the current wholesaler acquisition cost (WAC) of REMICADE, its reference product.