FDA withdraws biosimilar suffix proposal

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FDA withdraws biosimilar suffix proposal

Home/Guidelines | Posted 29/07/2016 0 Post your comment

The US Food and Drug Administration (FDA) has announced that it is withdrawing a request for comments on expanding the number of suffixes biosimilars makers can propose.

FDA published a notice in the Federal Register on 22 June 2016 stating that it was withdrawing the proposal that biosimilars developers could submit up to 10 random suffixes as part of the naming process for biologicals and biosimilars.

The original notice was published in the Federal Register on 2 June 2016 [1] and suggested that biosimilar makers should submit 10 preferred suffixes, with explanations supporting each, for the agency’s decision upon drug approval. The revision to 10 suffixes was thought by some to suggest that FDA was leaning towards the use of meaningful suffixes – especially since the guidance asked companies to list the suffixes in order of preference.

Dr Leah Christl, Associate Director for Therapeutic Biologics at FDA, however, has said that ‘10 was an arbitrary number the agency chose and not an indicator of a reversal toward the use of meaningful suffixes’.

FDA has stated that the notice was being withdrawn as it was issued due to an ‘administrative error’, but did not state any other reason for the withdrawal. Some have speculated that the agency wants to extend the comment period, which was originally to 2 July 2016.

Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA increases number of biological suffix proposals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jul 29]. Available from: www.gabionline.net/Guidelines/FDA-increases-number-of-biological-suffix-proposals

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Source: US FDA