On June 30, 2017, Pfizer, Inc. (“Pfizer”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 8,591,897...
BiosimilarsIP.com News section provides updates on current news and events related to biologics and biosimilars.
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By C. Nichole Gifford Comments are off
Celltrion announced last week that its Biologics License Application (“BLA”) for CT-P10, a biosimilar to Biogen and Genentech’s...
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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
We previously reported that after a public meeting held on May 25, 2017, the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended...
Tagged with: Amgen, epoetin alfa, Epogen®, FDA, Hospira, News, Pfizer, Regulatory
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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
The FDA announced yesterday that the Oncologic Drug Advisory Committee (“ODAC”) has scheduled a public meeting to review ABP 215,...
Tagged with: Allergan, Amgen, Avastin®, bevacizumab, FDA, Genentech, News, Regulatory
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