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.
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Mylan says it is now ready to launch its Semglee insulin glargine rival to Sanofi’s Lantus in the US upon FDA approval, after removing the final intellectual-property barriers by way of a favorable inter partes review decision.
Industry gets time to craft more objections to EU GMP PUPSIT provision, excipient data integrity advice offered, FDA MAPPs revised, US hits Health Solutions while EU hits Dishman Carbogen, and 11 added to FDA drug GMP import alert.
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.