Woodcock Bemoans Lack Of 'Biobetter' Provision In BPCIA

 
• By Michael Cipriano

CDER director lobbied for inclusion of a 505(b)(2)-like category for biologics, but it was ultimately not included in the 2010 legislation creating the biosimilar pathway; Woodcock urges patience on the development of the biosimilar marketplace and notes the agency will be keeping an eye on the development of biobetters, which are relatively new innovations.

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CDER Director Janet Woodcock discussed the future of the US biosimilars market.

While striking an overall optimistic tone on the future of the US biosimilars market, Center for Drug Evaluation and Research (CDER) director Janet Woodcock bemoaned the absence of a "biobetter" pathway from the Biologics Price Competition and Innovation Act (BPCIA).

Speaking on 23 September at the Drug Information Association's Biosimilars Conference, Woodcock said that despite her lobbying efforts for the...

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