Tag Archives: Inflectra

October, 2017

30 October
One Year Maintenance and Switching Data in Patients with Crohn’s Disease Support the Use of Inflectra in IBD

NEW YORK–(BUSINESS WIRE)–New data show that switching patients with Crohn’s disease (CD) to INFLECTRA (infliximab CT-P13) from REMICADE (infliximab) led to comparable efficacy, safety and tolerability to treatment with REMICADE over a 24 week period.1The full 54-week results of the randomized controlled trial comparing INFLECTRA and REMICADE in biologic-naïve patients …
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19 October
Pfizer Announces the US Availability of Biosimilar Inflectra

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the company will begin shipment of INFLECTRA® (infliximab-dyyb) for injection, a biosimilar of REMICADE®1 (infliximab) to wholesalers in the United States (U.S.) in late November 2016. INFLECTRA will be the first biosimilar monoclonal antibody (mAb) and only the second biosimilar to be …
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5 April
FDA Approves Celltrion’s Inflectra, a Biosimilar to Remicade

The U.S. Food and Drug Administration today approved 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 …
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21 August
TGA Approves Hospira’s mAb Biosimilar

MELBOURNE, Australia, Aug. 19, 2015 /PRNewswire/ — Hospira today announced that InflectraTM (infliximab), the first monoclonal antibody (mAb) biosimilar therapy, has been registered in Australia. This registration paves the way for the Federal Government to reduce the cost of some of the most expensive medicines on the Pharmaceutical Benefits Scheme (PBS). …
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11 June
Hospira Presents Positive Results for its Biosimilar Monoclonal Antibody Inflectra

Biosimilars drugmaker Hospira, Inc. announced results showing patients with rheumatic diseases experienced comparable clinical effectiveness and safety after switching from Janssen’s Remicade to Hospira’s Inflectra, the first biosimilar monoclonal antibody, which received approval from the European Commission (EC) in 2013. The Lake Forest-based company presented the data at the European …
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