Another Milestone For Emerging Biosimilar Companies

Celltrion received Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. 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;adult patients with chronic severe plaque psoriasis. After Positive node from FDA for its safety and efficacy, we were expecting an approval by Q3 2016. This was a pretty fast approval from FDA's end. Also Celltrion is coming up with more Phase 4 data, which i shall be collating in my next update As i track the generic companies in India, i have observed that FDA's has fasten its process both the generic and other approval. Also to note is that Samsung Bioepis (South Korea) has also received recommendation from EMA for its in-development biosimilars: Flixabi, a biosimilar of Janssen’s blockbuster Remicade for Inflammatory diseases.