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The BPCIA Transition: Products, Patents And Exclusivities

Executive Summary

Pink Sheet infographic looks at the 95 NDAs moving from regulation as drugs to biologics on 23 March; list includes 27 insulin products, seven of which have unexpired exclusivity that will not carry over when they are delisted from the 'Orange Book.'

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US Marks Biologics Transition Day

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.

Transition Day In The US: 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.

The Last Days Of NDAs: Uncertainties Remain Ahead Of 23 March Move From Drugs To Biologics

Exactly how many NDAs ultimately will make the switch, the impact of pending applications on 'Orange Book' listings, and the ramifications for ‘authorized generics’ are areas of focus as the regulatory transition date looms.

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