Biologic drugs are quickly reshaping the pharmaceutical landscape as they dominate the drug market in annual sales revenue. Abbvie’s Humira® (adalimumab) rocketed to the best-selling drug in the world with sales generating over $16 billion USD in 2016. The top biologic drugs are all driving revenues well beyond the $1 billion sales revenue demarcation that
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 June 30, 2017, Pfizer, Inc. (“Pfizer”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 8,591,897 (“the ’897 patent”) related to Genentech’s Herceptin® (trastuzumab). Pfizer has a trastuzumab biosimilar in phase III development, but it has not yet announced the filing of an application for that product with the
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 9, 2016, for inter partes review (“IPR”) of U.S. Patent No. 7,622,115 (“the ’115 patent”) related to Genentech’s Avastin® (bevacizumab). Interestingly, Genentech elected not to file a preliminary response. On March 16, 2017, the PTAB issued a decision
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
On March 10, 2017, the PTAB published a decision terminating the proceedings in IPR2016-1693 and IPR2016-1694 because the parties have reached a settlement. Mylan filed two petitions requesting inter partes review (“IPR”) of certain claims (1, 2, 4, 12, 25, 29-31, 33, 42, 60, 62-67, 69 and 71-81) of U.S. Patent No. 6,407,213 (“the ’213