FDA announced today that it has approved Genentech’s Ocrevus® (ocrelizumab) for the treatment of adults with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis (“PPMS”). Ocrevus is the first drug approved by the FDA for treatment of PPMS, which the CDC estimates affects 15% of patients with multiple sclerosis….
Sanofi and Regeneron announced yesterday that their Dupixent® (dupilumab) product has received FDA approval for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. As we reported last week, Sanofi and Regeneron have filed…
As we previously reported, a number of amici curiae have submitted briefs in support of each party in Sandoz v. Amgen. On March 17, Biotechnology Innovation Organization (“BIO”), a trade association representing various members of the biotechnology industry, filed an amicus brief in support of Amgen. The brief argues that…
Celltrion has filed two additional petitions for inter partes review of Genentech patents related to trastuzumab: IPR2017-01139, challenging U.S. Patent 6,627,196, and IPR2017-01140, challenging U.S. Patent 7,371,379. According to the Petitions, the patents are drawn to methods for treating cancer by administering trastuzumab and a chemotherapeutic agent. Trastuzumab is sold…
As we posted here, here, and here, various amicus briefs have been submitted in Sandoz v. Amgen. Last week, Janssen Biotech, Inc. submitted an amicus brief in support of Amgen. Janssen’s brief emphasizes two points. First, Janssen asserts that the express statutory purpose of the 180-day notice of commercial marketing is to…
This week Sanofi-Aventis and Regeneron Pharmaceuticals took aim at Amgen’s U.S. Patent No. 8,679,487 on two fronts, filing a declaratory judgment action in district court and a petition for inter partes review in the U.S. Patent & Trademark Office. The ’487 patent is directed to an “isolated human antibody that competes with…
Amgen announced yesterday that the European Commission (EC) has granted marketing authorization for AMGEVITA (biosimilar adalimumab) in all available indications, including certain adult and pediatric inflammatory diseases. AMGEVITA is Amgen’s first biosimilar approved by the EC. Amgen states in its press release that “AMGEVITA was approved in the United States (U.S.) by…
On February 17, 2016, we reported that Amgen and Sandoz had both petitioned the U.S. Supreme Court for review of the Federal Circuit’s decision in Amgen v. Sandoz, each seeking to advance their respective positions on whether the BPCIA patent dance is mandatory and whether/when notice of commercial launch must…
Celltrion has filed petitions for inter partes review of two patents related to Genentech’s trastuzumab: IPR2017-01121, challenging U.S. Patent 7,846,441, and IPR2017-01122, challenging U.S. Patent 7,892,549. According to the petitions, these two patents claim methods of treating patients with a sub-type of breast cancer with trastuzumab. These filings follow Celltrion’s…
During his presentation this month at the Cowen and Company 37th Annual Health Care Conference, Amgen’s Executive Vice President and Chief Financial Officer David Meline indicated that Amgen has filed for approval in the EU for their ABP 980 biosimilar (trastuzumab). Mr. Meline also indicated that Amgen is looking to file for…