Mylan's Lantus Rival Faces Fresh Attack
Sanofi Tries To Stop Biosimilar Via Supreme Court PTAB Review
Sanofi seeks to delay decision clearing path for Mylan's Lantus biosimilar; says it should be able to get rehearing based on Federal Circuit's ruling that PTAB judges were not constitutionally appointed.
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A US district court has ruled in favor of Mylan in a dispute with Sanofi over a Lantus SoloStar device patent, with the patent protecting the insulin glargine injector pen found to be invalid and not infringed. Mylan, along with partner Biocon, expects to launch its Semglee version mid-year, following FDA approval.
Biocon and Mylan press ahead with plans to broaden patient access in the US to biosimilar pegfilgrastim and are enthused with the initial uptake for their trastuzumab biosimilar ahead of more upcoming competition. A mid-2020 US launch for partnered insulin glargine is also on course.
Bill addresses ‘dead zone’ for pending applications for protein products transitioning to biologic status; generic and brand industries each win in different legislative provisions: inclusion of the CREATES Act, and a revised definition for ‘biologics’ that includes chemically synthesized polypeptides.