In a move that has attracted attention from industry, the judiciary, and Congress, Allergan, Inc. assigned its rights to patents covering its Restasis® dry eye treatment to the St. Regis Mohawk Tribe (“Tribe”) and simultaneously licensed back those patents in exchange for the Tribe’s agreement to invoke tribal sovereign immunity in inter…
Below are some highlights from third quarter earnings reports recently released by biologics and biosimilar companies. Johnson & Johnson reported that Remicade (infliximab) sales declined more than 1% in the U.S. and more than 8% worldwide year-over-year. During its earnings call, company executives explained that two-thirds of the decline in sales in Europe…
Below is an update on recent developments in several litigations involving biosimilar products. AbbVie v. Boehringer Ingelheim (adalimumab): On October 23, the parties filed a joint status report. Among other things, the parties offered their competing proposals for the schedule and the scope of discovery, including limits on the number…
Yesterday, Momenta and Mylan reported that initial results obtained from their proposed abatacept biosimilar M834 did not meet primary pharmacokinetic endpoints in a Phase I study comparing the pharmacokinetics, safety and immunogenicity of M834 to US- and EU-sourced ORENCIA in 243 normal healthy volunteers. The Phase I study was a randomized,…
This week Roche reported that FDA has accepted their supplemental Biologics License Application (sBLA) for Avastin® (bevacizumab) “in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of women with advanced ovarian cancer.” The sBLA is for the use of Avastin® with carboplatin and paclitaxel,…
The United States District Court for the District of Massachusetts has denied Celltrion’s motion to dismiss the action for lack of standing. As we previously reported, Celltrion argued that certain co-owners of the ’083 patent-in-suit were not parties to the action when Janssen filed its 2015 complaint, and that Janssen’s attempts to…
Last year we reported the FDA approval and then U.S. launch of Inflectra®, a biosimilar of Remicade® (infliximab). This week, Pfizer and Celltrion Healthcare have reported that the results of a Phase 3 study of Inflectra demonstrated that “switching patients with Crohn’s disease (CD) to Inflectra from Remicade® (infliximab) led…
The PTAB remains a busy venue for biologics patents. Here are some IPR updates from the weeks since our last IPR update: HERCEPTIN On October 4, the Board instituted IPR on four petitions that Celltrion had filed on Genentech patents related to Herceptin® (trastuzumab): IPR2017-01121 (challenging U.S. Patent 7,846,441); IPR2017-01122 (challenging U.S. Patent No….
Today, Sandoz announced that its biosimilar of Neulasta® (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review. According to the press release, the data package submitted as part of the Marketing Authorization Application “strongly demonstrates that the biosimilar pegfilgrastim matches the reference medicine in terms of safety,…
Earlier this month, the Federal Circuit vacated an injunction in the Amgen v. Sanofi litigation that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product in the United States until expiration of the patents-in-suit. Today, Amgen filed a motion to extend the time for it to file…