Pfizer to Launch J&J Remicade Biosimilar in U.S.

Oct. 18, 2016

Pfizer Inc. announced it will begin shipment of Inflectra (infliximab-dyyb) for injection, a biosimilar of REMICADE (infliximab) to wholesalers in the United States 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., according to Pfizer. It is approved for the treatment of:

1) 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;

2) Adult patients with moderate to severely active ulcerative colitis who have had an inadequate response to conventional therapy; and

3) 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. “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.

In a related Reuters story, J&J shares dropped 2 percent because of worries that its Remicade arthritis drug would soon face cheaper competition. Read the Reuters story.