Mylan/Biocon’s Insulin Glargine Would Get A Respite Under US Budget Legislation
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.
You may also be interested in...
Agency's final rule defines protein based on size of amino acid sequence, irrespective of method of manufacture, saying this 'bright-line rule' provides regulatory certainty.
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.
Association for Accessible Medicines’ interim leader is General Counsel Jeffrey Francer; Chip Davis’ four-and-half year tenure included a total rebrand of the association, a significant legislative victory with the CREATES act – and an abrupt departure for the Healthcare Distribution Alliance.