On Jul 19, 2019, Delaware court denied both motions filed by Genentech.
Genentech filed 2 motions which require Amgen to provide new 180-day commercial marketing notice & temporary restraining order (TRO). Amgen’s biosimilar (Mvasi : bevacizumab-awwb) product was approved in Sep 2017. In Oct. 2017, Amgen sent Genentech a Notice of Commercial Marketing Under§ 262(1)(8)(A). Amgen then filed supplements which FDA approved in Dec. 2018 & Jun. 2019 for change in drug substance manufacturing facility & change in labeling respectively. On July 10, 2019, Genentech filed above 2 motions.
Genentech argued that Mvasi product made pursuant to the specifications approved by the FDA in June 2019 is “a distinct ‘product licensed under subsection (k)’ requiring its own notice” because it is “a new product made by a new manufacturing process, accompanied by a new label, and the subject of separate applications, FDA reviews, and FDA approvals. But Court denied the motions & held that Amgen is not required to give new marketing notice because it is the same product. Though FDA approved the later supplements which require facility & labelling changes but it does change “biological product”. BPCIA’s language makes clear that a biologic product is not defined by its manufacturing facilities or labeling. Court also said that nothing in the BPCIA states or even suggests that an applicant cannot file or the FDA cannot approve a supplement filed after the FDA approved the underlying application (or an earlier supplement).
With respect to TRO, court already found that Genentech cannot succeed on the merits because it has failed to establish a likelihood of success & thus denied this motion also.
Leave a Reply