Recreational Marijuana Use Legalized in NYS – Your Questions Answered
On March 8, 2022, Alvotech announced that it has executed a U.S. settlement agreement with Abbvie that grants Alvotech non-exclusive rights to market AVT02 (adalimumab) in the U.S starting July 1, 2023. AbbVie confirmed the...more
On January 28, 2021, Bio-Thera Solutions, Ltd., a biopharmaceutical company based in China, announced that the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for BAT1706, a proposed...more
On November 18, 2020, companies Samsung Bioepis Co., Ltd. and Biogen Inc. announced that the United States Food and Drug Administration (“FDA”) accepted for review the Biologics License Application for SB11, a proposed...more
A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an FDA-approved reference biological product. Biosimilar applicants have a number of choices to make on the path...more
The FDA issued a draft guidance today titled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.” In this guidance, the FDA...more
On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug Competition Action Plan (DCAP), FDA finally unveiled its plan for...more
In a Report and Recommendation issued December 7, 2017, Magistrate Judge Burke in the District of Delaware recommended that Amgen’s BPCIA complaint for infringement against Coherus Biosciences Inc. be dismissed with prejudice...more
The Supreme Court could issue its decision in the Amgen v. Sandoz biosimilar patent dance case any day now. Last week I participated in a panel discussion with industry stakeholders considering how the decision might–or might...more
On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more
The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz,...more
On Friday, Jan. 13, the Supreme Court granted the appellant’s petition and the respondent’s cross-petition for a writ of certiorari in Sandoz Inc. v. Amgen Inc. This is the first time the Court will construe the Biologics...more