Tagged as: Infliximab

Positive Results From Ustekinumab Biosimilar Phase I Trial and Infliximab Biosimilar Switching Studies

On October 20, 2020, NeuClone announced that it successfully completed its Phase I clinical trial of NeuLara, its proposed biosimilar of Stelara (ustekinumab).  According to Neuclone, the Phase I clinical trial demonstrated similar clinical pharmacokinetics, and safety, immunogenicity and tolerability profiles of NeuLara compared to US- and EU-sourced Stelara.  NeuLara…

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Merck Transfers Biosimilars and Other Products to Spinoff Company

Last week, Merck announced its intention to spin-off products from its Women’s Health, legacy brands, and biosimilars businesses into a new, yet-to-be-named, independent, publicly traded company.  According to Merck, “NewCo will pursue global leadership and focused, sustainable growth in Women’s Health led by the growing and patent-protected NEXPLANON (etonogestrel implant)…

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Phase III study report indicates Celltrion and Pfizer’s infliximab biosimilar is non-inferior to REMICADE in treating Crohn’s disease

According to a recent paper in The Lancet, a new phase 3 study shows that CT-P13, Celltrion and Pfizer’s infliximab biosimilar, is non-inferior to the reference biologic, REMICADE, for the treatment of Crohn’s disease.  CT-P13 was approved by the European Commission under the trade name Remsima® in September 2013, and…

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Breaking News Update – Janssen v. Celltrion: District Court Rules in Favor of Celltrion on Summary Judgment of Non-Infringement

Today, Judge Wolf found in favor of Celltrion, granting its motion for summary judgment of non-infringement of the sole remaining patent-in-suit based on an application of the ensnarement doctrine to Janssen’s infringement theory under the doctrine of equivalents.  The Court determined that Celltrion’s infliximab biosimilar does not infringe Janssen’s ’083…

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Celltrion Healthcare Presents Research Demonstrating Positive Results for Use of Biosimilar Infliximab in Treatment of Crohn’s Disease and Rheumatoid Arthritis

Celltrion Healthcare recently presented research from two studies conducted on its CT-P13 subcutaneous (SC) formulation (biosimilar infliximab) demonstrating positive results for the use of CT-P13 SC in the treatment of active Crohn’s disease and rheumatoid arthritis.  According to Celltrion, the data from each study shows the efficacy and safety of…

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Celltrion Moves for Summary Judgment in Janssen v. Celltrion

Last week, in the ongoing Janssen v. Celltrion litigation concerning Celltrion’s Inflectra®, a biosimilar of Janssen’s Remicade® (infliximab), Judge Wolf of the U.S. District Court for the District of Massachusetts granted Defendants’ unopposed motion for leave to file a motion for summary judgment and accompanying briefing schedule.  In their summary judgment brief, filed on…

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