Last week the Biosimilars Council submitted an amicus brief in the Federal Circuit remand proceedings for Amgen v. Sandoz, arguing that Amgen’s state-law claims for Sandoz’s failure to comply with the patent dance’s disclosure provisions are preempted by federal law under both field preemption and conflict preemption. The brief is…
Goodwin’s Intellectual Property and Life Sciences teams won three awards, and were shortlisted in 10 categories for over 10 awards, at the 2017 LMG Life Sciences Awards hosted in New York City on September 13. The awards recognized and honored the leading attorneys, firms and in-house counsel teams who have…
As we previously reported, last month AbbVie filed a complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira (adalimumab) product. Yesterday, BI filed an answer to AbbVie’s complaint, which includes counterclaims against AbbVie for declarations of patent invalidity and non-infringement. In support…
Today, the FDA announced that it has approved Mvasi® (bevacizumab-awwb), Amgen’s biosimilar of Genentech’s Avastin®. According to the announcement, Mvasi® is the first biosimilar that the FDA has approved for the treatment of cancer. Mvasi® is indicated for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic…
This morning, the district court in Janssen v. Samsung Bioepis, which concerns Samsung Bioepis’ Renflexis® (infliximab-abda) biosimilar product, entered a pretrial scheduling order. The scheduling order calls for, among other things, fact discovery to close on August 30, 2018, expert discovery to close on January 31, 2019, and any dispositive motions…
At the European Society for Medical Oncology (“ESMO”) 2017 Congress, which was held over the past several days in Madrid, Spain, companies presented Phase 3 clinical data regarding two investigational biosimilars of Herceptin (trastuzumab). First, Amgen presented Phase 3 study data on ABP980, which it is co-developing with Allergan plc, comparing the safety…
According to press releases this week, the FDA has recently accepted two new Abbreviated Biologics License Applications (aBLA) for review. First, Adello Biologics yesterday announced that the FDA has accepted its aBLA for its proposed biosimilar of Neupogen® (filgrastim), which is indicated for, among other things, the treatment of neutropenia-related…
Yesterday, in the remanded appeal in Amgen v. Sandoz, the United States submitted an amicus brief to the Federal Circuit that generally supports the position taken by Sandoz and the Biosimilars Council that Amgen’s state-law claim for an injunction under California’s Unfair Competition Law (“UCL”) or tort damages to enforce compliance with…
With the September 18, 2017 trial date fast approaching, the district court in Amgen v. Hospira last week denied Hospira’s motion for summary judgment of non-infringement of its proposed biosimilar of Epogen®/Procrit® (epoetin alfa) and granted-in-part and denied-in-part the parties’ respective motions for exclusion of expert testimony. As we previously…
Last week Fresenius Kabi announced that it has successfully closed its acquisition of Merck KGaA’s biosimilars business, which comprises Merck’s entire biosimilars development pipeline. According to Fresenius, the product pipeline is focused on oncology and autoimmune diseases. Further information about the financial terms of the deal, which was originally announced in…