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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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.'
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.
After 23 March, the US FDA won’t allow any more bulk compounding of four oft-compounded drug substances, disrupting patient care, compounders say.