Pfizer plans to launch REMICADE biosimilar in US in November

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 Essential Health Business regional president North America Diem Nguyen said: “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.

“We are proud of our global leadership in biosimilars, and will continue our efforts to advance a sustainable, competitive marketplace for these therapies to deliver a high quality, consistent supply of product and long-term savings and value for patients and physicians.”

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.