The end of 2017 has been bustling with oncology biosimilar news. On December 20, 2017, the Food and Drug Administration (FDA) accepted Samsung Bioepis’ application for SB3, its biosimilar version of trastuzumab. The drug would be the fourth to undergo evaluation by the FDA, and may pack on the pressure for Mylan and Biocon’s product … Continue reading Fourth Herceptin® Biosimilar Being Evaluated by FDA
Tag: Celltrion
A Pre-Holiday Gift for Pfizer—a Second Infliximab Biosimilar Approval. Now What?
On December 14, Pfizer got an early Christmas present, the approval by the Food and Drug Administration (FDA) of the second infliximab biosimilar in which it has a stake. First came Inflectra® in 2016, and here comes Ixifi™ (infliximab-qbtx). Unlike Inflectra, which Pfizer markets for Celltrion, Ixifi is Pfizer’s alone—a product that was under development … Continue reading A Pre-Holiday Gift for Pfizer—a Second Infliximab Biosimilar Approval. Now What?
Fuzzy Patent Logic
Three other biosimilar manufacturers have already filed for approval in the US: Amgen/Allergan and Celltrion/Teva (separately) in July 2017; Mylan/Biocon in November 2016. Roche settled its patent claims against Mylan in March 2017, which provides Mylan with a license to sell its biosimilar version of Herceptin® should it gain FDA approval next year.
Rituximab and Filgrastim Biosimilars Being Reviewed by FDA
Sandoz's Rituximab and Adello Biologic' Filgrastim Biosimilars Submitted to FDA
Inflectra Sales Lagging for Pfizer in Second Quarter
“Our Inflectra share was 2.3% of the overall infliximab volume,” including both patients who had not used infliximab before and those who switched to Inflectra.
Two New Trastuzumab Biosimilars Submitted for FDA Approval
The team of Mylan and Biocon may have some company in the biosimilar competition for Herceptin® (trastuzumab). Two additional partnerships announced the filing of their 351(k) applications for trastuzumab biosimilars. Amgen and Allergan are hoping ABP 980 will have smooth sailing through the approval system. The phase 3 study in patients with early-stage HER2-positive breast … Continue reading Two New Trastuzumab Biosimilars Submitted for FDA Approval
Biosimilar Rituximab Under FDA Review
Celltrion announced June 30, 2017 that it has submitted its 351(k) application to the Food and Drug Administration for approval of its biosimilar version of rituximab. This represents the first biosimilar application for rituximab, a monoclonal antibody to CD20.
Celltrion’s Rituximab Recommended for Approval in Europe
Just weeks after Celltrion presented data at the American College of Rheumatology meeting demonstrating that its product CT-P10 is as safe and effective as Rituxan® for the treatment of rheumatoid arthritis (RA), the European Medicines Agency (EMA) received the recommendation to approve the product for use in the EU.