In a study published in Clinical Therapeutics on April 22, AryoGen Pharmed’s proposed bevacizumab biosimilar, BE1040V (STIVANT), was found to be noninferior to the reference product (AVASTIN) in a Phase III clinical trial in patients with metastatic colorectal cancer. AryoGen Pharmed is a pharmaceutical manufacturer based in Iran that specializes…
April has seen a flurry of biosimilar-related appellate activity before the Federal Circuit. Below are some highlights. The parties in the Amgen v. Hospira BPCIA litigation concerning Hospira’s RETACRIT (epoetin alfa-epbx) biosimilar concluded appellate briefing this month. As we previously reported, Hospira is appealing the district court’s adverse judgment that…
As we previously reported, Pfizer recently filed a notice that it will not participate in the appeal of the final written decision of IPR2017-01168, which found all claims of U.S. Patent No. 8,821,873 unpatentable. The ‘873 patent is directed to a method of treating lymphoma with anti-CD20 antibodies. On March…
On Wednesday, the FDA approved the first biosimilar to Genentech’s RITUXAN®. The FDA’s press release noted that Teva and Celltrion’s biosimilar TRUXIMA® (rituximab-abbs) is the first biosimilar to be approved in the U.S. for the treatment of non-Hodgkin’s lymphoma. TRUXIMA® is indicated for treatment of adult patients for: Relapsed or…
On November 1, 2018, Genentech and its co-plaintiffs dismissed the lawsuits they brought against Celltrion and Teva under the BPCIA in the District of New Jersey, in which the plaintiffs alleged that Celltrion’s filing of an aBLA relating to Truxima®, Celltrion’s proposed biosimilar to Rituxan® (rituximab), infringed certain patents. The…
As reported here, the Oncologic Drug Advisory Committee (ODAC) held a public hearing today at the U.S. Food & Drug Administration to discuss and vote on Celltrion’s Biologics License Application for CT-P10, a proposed biosimilar of Genentech’s U.S.-licensed rituximab product Rituxan. The hearing included presentations from various speakers from industry,…
On November 11, 2017, Pfizer, Inc. filed a petition for inter partes review (IPR) of Biogen and Genentech’s US Patent No. 8,545,843, which relates to a method of treating vasculitis with rituximab. (IPR2018-00086.) On May 31, 2018, the PTAB denied institution of this IPR. Separately, on June 4, 2018, Pfizer filed…
Below is a rundown of some recent developments in BPCIA litigations concerning biosimilars of Genentech’s Herceptin® (trasuzumab), Rituxan® (rituximab), and Avastin® (bevacizumab). Celltrion v. Genentech (trastuzumab) and Celltrion v. Genentech (rituximab) As we previously reported, on January 11, 2018, Celltrion and Teva filed two lawsuits against Genentech in the District…
We previously reported that on December 21, 2017, Genentech filed suit against Sandoz in the District of New Jersey based on Sandoz’s proposed rituximab biosimilar, Rixathon/GP2013. On April 23, 2018, Judge Renee Marie Bumb held an in-person status conference and set forth a preliminary injunction briefing schedule. The Court ordered the motion for preliminary…
We previously reported that on September 12, 2017, the FDA accepted for review Sandoz’s aBLA for a proposed biosimilar of Rituxan® (rituximab), which is indicated for the treatment of certain blood cancers and immunological diseases. Yesterday, Genentech filed a complaint in the District of New Jersey based on Sandoz’s proposed rituximab biosimilar, Rixathon/GP2013. Genentech…