Celltrion announced last week that its Biologics License Application (“BLA”) for CT-P10, a biosimilar to Biogen and Genentech’s...
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On June 19, 2017, the European Commission (EC) approved Sandoz’s Rixathon® (rituximab), a biosimilar to Roche/Genentech’s...
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We previously reported that after a public meeting held on May 25, 2017, the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended...
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On June 22, 2017, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicine’s Agency (“EMA”)...
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Fujifilm Kyowa Kirin Biologics announced that its Medical Marketing Application (“MMA”) for FKB327, a biosimilar to AbbVie’s Humira®...
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The FDA announced yesterday that the Oncologic Drug Advisory Committee (“ODAC”) has scheduled a public meeting to review ABP 215,...
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On May 25, 2017, Pfizer, Inc. (“Pfizer”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 6,407,213...
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Pfizer announced last week that the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended its proposed biosimilar to Amgen’s...
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Last week, Celltrion, Inc. (“Celltrion”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 6,407,213...
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