April 5, 2016, marks a revolutionary day in the treatment of autoimmune diseases: The U.S. Food and Drug Administration (FDA) approved an infliximab (Remicade) biosimilar, known as Inflectra (infliximab-dyyb). Infliximab-dyyb, which is administered by intravenous infusion, is the first biosimilar drug approved to treat rheumatic disease in the U.S.1
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Explore This IssueMay 2016
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Infliximab-dyyb has received approval for almost all of the indications of the reference product. These include:
- Adult patients and pediatric patients (ages 6 years and older) with moderate to severe active Crohn’s disease who have had an inadequate response to conventional therapy (but not pediatric ulcerative colitis [UC]);
- Adult patients with moderate to severe active UC who have had an inadequate response to conventional therapy;
- Patients with moderate to severe active rheumatoid arthritis in combination with methotrexate;
- Patients with active ankylosing spondylitis;
- Patients with active psoriatic arthritis; and
- Adult patients with chronic severe plaque psoriasis.
Prescribing information is already available on the FDA website at Drugs@FDA and in the Purple Book.2
In a statement released April 6, the ACR welcomed the introduction of biosimilars to the U.S. healthcare system.3 It is “hopeful that the decrease in cost resulting from the availability of safe and effective biosimilars in the U.S. will increase our patients’ access to life-changing therapies and improve their overall health.
“While America’s rheumatologists support the development of new biosimilar therapies, the safety of our patients remains our highest priority. As such, we encourage the FDA to continue to apply distinct names for future biosimilars, and to maximize clarity in the labeling of biosimilars, specifically with respect to their interchangeable status and the origins (reference drug vs. biosimilar) of clinical data upon which FDA approval is based.”
FX006 Meets Primary Endpoint for Knee OA
FX006 (Zilretta) is an intra-articular, non-opioid anti-inflammatory drug that has received a fast-track designation from the FDA.4 This intra-articular, sustained-release injection employs proprietary microsphere technology combining triamcinolone acetonide (TCA) with the polymer poly lactic-co-glycolic acid to provide persistent drug concentrations locally and prolong the duration of pain relief.
In a recent Phase 3, placebo-controlled, active-comparator trial, patients were randomized to receive one of three treatments (1:1:1): a single 40 mg FX006 injection, placebo or 40 mg TCA immediate-release injection. The primary study objective was to assess the magnitude of pain relief at Week 12 compared with placebo. The secondary objectives were to assess the magnitude and duration of pain relief and effect compared with placebo and immediate-release TCA.