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Mylan/Biocon’s Insulin Glargine Would Get A Respite Under US Budget Legislation

Executive Summary

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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Generic Drug Sponsors Would Get More Info On Brand Inactive Ingredients Under User Fee Bill

PhRMA expresses concerns the provision would reveal trade secrets, but since the draft bill already has support from the Republican committee leadership, the brand industry may find it a challenge to get the language removed.

Generic Drug Sponsors Would Get More Info On Brand Inactive Ingredients Under User Fee Bill

PhRMA expresses concerns the provision would reveal trade secrets, but since the draft bill already has support from the Republican committee leadership, the brand industry may find it a challenge to get the language removed.

Is CREATES Act Equipped To Handle Biosimilar Complaints?

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