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.'
The US Food and Drug Administration currently estimates 95 new drug applications approved under the Food, Drug and Cosmetic Act will transition to regulation as biologics under the US Public Health Service Act on 23 March.
With the help of the FDA’s “Orange Book,” the Pink Sheet took a close look at the affected products, including...
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The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
