Mylan And Biocon's Insulin May Get US Reprieve
Insulin Glargine Application Would Get 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.
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Industry has welcomed the passage of the CREATES Act in the US, which is aimed at curbing originator attempts to deny access to samples by abusing FDA safety programs.
After second complete response letter, Mylan and Biocon have just over six months to resolve manufacturing issues and obtain full approval or face having to resubmit the insulin as a biologics license application.
Broad bipartisan support and billions in projected savings mean that bill may finally pass. But whether it will work as intended to improve generic access to market remains as questionable as ever.