Amgen and Allergan recently announced that they submitted a Biologics License Application (“BLA”) for ABP 980, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab), to the Food and Drug Administration (“FDA”).  According to the press release, Amgen and Allegan have “formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines.”

Novartis’ First CAR-T Cell Therapy Tisagenlecleucel (CTL019)

The FDA’s Oncologic Drug Advisory Committee (“ODAC”) held a public meeting on Wednesday, July 12, 2017, to consider Novartis’ biologic license application (BLA 125646) for tisagenlecleucel (CTL019), an investigational chimeric antigen receptor T cell (“CAR-T”) therapy.  Novartis is seeking approval of CTL019 for the treatment of patients from

On May 25, 2017, Pfizer, Inc. (“Pfizer”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 6,407,213 (“the ’213 patent”).  The ‘213 patent, entitled “Method for Making Humanized Antibodies,” issued on June 18, 2002.  Although the IPR petitions do not identify a particular biologic, Genentech has publicly stated that the technology

Last week, Celltrion, Inc. (“Celltrion”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 6,407,213 (“the ’213 patent”) related to Genentech’s Herceptin® (trastuzumab).  Celltrion has announced that it plans to submit an application for a trastuzumab biosimilar product to the FDA this year (possibly as early as next month), as reported

On March 21, 2017, Celltrion, Inc. (“Celltrion”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent Nos. 7,846,441 (“the ’441 patent”) and 7,892,549 (“the ’549 patent”). Three days later, on March 24, 2017, Celltrion filed two additional IPR petitions for U.S. Patent Nos. 6,626,196 (“the ‘196 patent”) and 7,371,379 (“the ‘379 patent”).  

Hospira, Inc. (“Hospira”) filed a petition with the Patent Trial and Appeal Board (“PTAB”) on September 16, 2016 for inter partes review (“IPR”) of U.S. Patent No. 7,807,799 (“the ’799 patent”) related to Genentech’s Herceptin® (trastuzumab).  On March 15, 2017, the PTAB issued a decision instituting review of claims 1–3 and 5–11 of the

Celltrion, Inc. (“Celltrion”) filed a new petition with the Patent Trial and Appeal Board (“PTAB”) on February 21, 2017 for inter partes review (“IPR”) of U.S. Patent No. 8,591,897 (“the ’897 patent”) related to Genentech’s Herceptin® (trastuzumab).  The challenged claims of the ’897 patent are directed to methods for treating patients with nonmetastatic HER2-positive