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Inflectra (Infliximab-Dyyb), Second U.S. Biosimilar, to Begin Shipping in November
Pfizer, Inc., will begin shipment of Inflectra (infliximab-dyyb) for injection, a biosimilar of blockbuster arthritis drug Remicade (infliximab, Janssen Biotech), to U.S. wholesalers in late November 2016. The product will be the first biosimilar monoclonal antibody and only the second biosimilar to be available in the U.S.
Inflectra will be introduced at a 15% discount to the current wholesale acquisition cost (WAC) of Remicade, its reference product. WAC is not inclusive of discounts to payers, providers, distributors, and other purchasing organizations.
Inflectra was approved by the FDA in April 2016 for the treatment of:
- Adult patients and pediatric patients (ages 6 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.
“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 health care system,” said Diem Nguyen, regional president North America of Pfizer Essential Health Business. Pfizer holds exclusive commercialization rights to Celltrion’s Inflectra in the U.S., and has already successfully introduced the product in other markets across the globe.
Source: Pfizer; October 17, 2016.