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FDA plans to release four biosimilar guidances during 2015

Home/Guidelines | Posted 20/03/2015 0 Post your comment

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is planning to release four new guidance documents on biosimilars during calendar year 2015.

The guidance documents planned are as follows:

Biosimilars: additional questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009
Considerations in demonstrating interchangeability to a reference product
Labelling for biosimilar biological products
Statistical approaches to evaluation of analytical similarity data to support a demonstration of biosimilarity

The announcement came in an updated ‘Guidance Agenda’ document the agency publishes each year. CDER’s current list of documents now contains more than 90 guidance documents it plans to either release or finalize during 2015.

The news of additional biosimilars guidances can only come as a positive development for industry groups, who have been calling for FDA to promptly issue appropriate guidance on the issue of naming, as well as to issue or finalize guidances on other outstanding issues such as establishing interchangeability.

FDA releases 53 new and revised bioequivalence guidelines for generics

Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 20]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar

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Source: FDA