European Medicines Agency newly approves two adalimumab biosimilars U.S. Food & Drug Administration approves first bevacizumab...
EMA
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By Seth Cockrum Comments are off
Sandoz announced that its biosimilar application for Neulasta® (pegfilgrastim) has been accepted for regulatory review by the European...
Tagged with: EMA, Neulasta®, pegfilgrastim, Sandoz, Zioxtenzo
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Update: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
By Andrew Storaska and Aydin Harston Comments are off
European Medicines Agency newly approves five rituximab biosimilars and an etanercept biosimilar, while recommending approval of...
Tagged with: BPCIA, EMA, FDA, Regulatory
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By Andrew Storaska Comments are off
On June 19, 2017, the European Commission (EC) approved Sandoz’s Rixathon® (rituximab), a biosimilar to Roche/Genentech’s...
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By C. Nichole Gifford Comments are off
On June 22, 2017, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicine’s Agency (“EMA”)...
Tagged with: AbbVie, adalimumab, Biogen, EMA, FDA, Humira®, Imraldi®, News, Regulatory, Samsung Bioepsis
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By C. Nichole Gifford Comments are off
Fujifilm Kyowa Kirin Biologics announced that its Medical Marketing Application (“MMA”) for FKB327, a biosimilar to AbbVie’s Humira®...
Tagged with: AbbVie, adalimumab, AstraZeneca, Avastin®, bevacizumab, EMA, FDA, Fujifilm Kyowa Kirin, Humira®, News, Regulatory
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By C. Nichole Gifford Comments are off
Celltrion announced last week that it has submitted an application for approval of Herzuma, its proposed trastuzumab biosimilar (CT-P6), in...
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By C. Nichole Gifford Comments are off
Amgen’s Amgevita, an adalimumab biosimilar to AbbVie’s Humira®, received approval from the European Commission on March 23, 2017. ...
Tagged with: AbbVie, adalimumab, Amgen, EMA, FDA, Humira®, News, Regulatory
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By C. Nichole Gifford Comments are off
Celltrion’s Truxima (CT-P10, rituximab), a biosimilar to Rituxan® received approval from the European Commission on February 22, 2017. ...
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