Today, the FDA announced that it has approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar to Genentech and Roche’s Herceptin (trastuzumab). Ogivri is indicated for adjuvant treatment of breast cancer and treatment of metastatic breast cancer or stomach cancer in patients whose tumors overexpress the HER2 gene. Ogivri is the first biosimilar version…
Next Tuesday (December 5) between 1:00-2:30pm (EST), FDA’s Division of Drug Information is presenting a webinar titled an “Overview of the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S.” The webinar will provide an overview of the regulatory framework for biosimilar products, “including a background,…
As we previously reported, Amgen and Hospira both filed motions asking the Court to partially set aside the jury verdict in the Amgen v. Hospira litigation. In its motion, Hospira had asked the Court to set aside the jury verdict as to its accused batches under the § 271(e)(1) safe harbor, and…
We previously posted that Coherus had filed a motion to stay discovery in Amgen v. Coherus (involving pegfilgrastim) pending resolution of Coherus’s motion to dismiss. On September 13, Coherus withdrew its motion to stay. The court subsequently entered a scheduling order, setting a 5-day trial starting September 16, 2019. Meanwhile,…
Biocon Ltd., a biopharmaceutical company based in India, develops, manufactures and supplies products to treat diabetes, cancer, and autoimmune conditions. Last week, Biocon launched KRABEVA®, a bevacizumab biosimilar for the treatment of metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian, and brain cancers in India. Biocon reports…
The Supreme Court today considered the constitutionality of the IPR statute in a lively hour-long oral argument before a packed courtroom. The case, Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, asks whether the invalidation of patents in an IPR by the non-Article III judges of the Patent…
Below is our fall update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016, Midwinter 2017, Spring 2017, Summer 2017).
As we previously reported, the United States District Court for the District of Massachusetts denied Celltrion’s motion to dismiss for lack of standing in the Janssen v. Celltrion case. On November 14, 2017, Celltrion filed a motion to certify the court’s order for interlocutory review by the Federal Circuit. In…
On November 14, 2017, Theradiag, a French company specializing in in vitro diagnostics, announced that it had entered into a partnership agreement with Biogen to provide LISA TRACKER kits for monitoring Flixabi®, Biogen’s infliximab biosimilar that is marketed in Europe. Theradiag’s LISA TRACKER kits allow clinicians to monitor trough plasma…
We post frequently about citizen petitions here on the blog. Since the 1970s, the citizen petition process has allowed individual persons or organizations to request that FDA take or not take certain regulatory actions, such as not approving pending new drug applications. In recent years, the citizen petition process has come…