FDA Approves 2nd Biosimilar for J&J's Remicade

April 6, 2016

The U.S. FDA approved Inflectra (infliximab-dyyb) for multiple indications, and it is
administered by intravenous infusion. This is the second biosimilar approved by the FDA.

Inflectra is a biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was
originally licensed in 1998. Inflectra is manufactured by Celltrion, Inc., based in Yeonsu-gu,
Incheon, Republic of Korea, for Hospira, of Lake Forest, Illinois. Inflectra is approved and
can be prescribed by a health care professional for the treatment of:

• Adult patients and pediatric patients (ages six years and older) with moderately to severely
active Crohn’s disease who have had an inadequate response to conventional therapy;
• Adult patients with moderately to severely active ulcerative colitis who have had an inadequate
response to conventional therapy;
• Patients with moderately to severely active rheumatoid arthritis in combination with methotrexate;
• Patients with active ankylosing spondylitis (arthritis of the spine);
• patients with active psoriatic arthritis and;
• Adult patients with chronic severe plaque psoriasis.

The FDA’s approval of Inflectra is based on review of evidence that included structural and
functional characterization, animal study data, human pharmacokinetic and pharmacodynamics
data, clinical immunogenicity data and other clinical safety and effectiveness data that
demonstrates Inflectra is biosimilar to Remicade. Inflectra has been approved as biosimilar,
not as an interchangeable product.

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