US Marks Biologics Transition Day
FDA Sees 96 Drugs Make The Move To Biologics Regulation
Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.
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Draft legislative text would allow some biologics and biosimilars to rely on published literature or other information and avoid some clinical studies, but the wide FDA discretion also included could raise more questions.
Civica Takes First Foray Into Biosimilars With GeneSys Insulins Partnership
Non-profit generics firm Civica is partnering with GeneSys Biologics to make affordable biosimilars of Lantus, Humalog and Novolog for the US market, which it aims to sell at $30 a vial or $55 per pack of cartridges.
AmerisourceBergen Sees Momentum Build In US Biosimilars
AmerisourceBergen’s senior director of biosimilars, Sean McGowan, believes that momentum is continuing to build for US biosimilars in 2021, especially with key developments involving insulins and interchangeability on the horizon.