The Biotechnology Industry Organization (BIO) in the US has said that it ‘supports the development of a well-constructed pathway for the approval of biosimilars’, adding that the establishment of user fees for biosimilars ‘presents unique challenges compared to existing programs’. BIO also acknowledged that biosimilar applications ‘will raise novel and complex questions of science and law, requiring substantial time, expertise, and additional resources to ensure a thorough regulatory review’.

However, the European Biopharmaceuticals Group, part of the European Generic medicines Association (EGA), considers the FDA proposal excessive since the review workload for biosimilars is significantly lower than for a new biological.

On 9 May 2011, the FDA proposed a user fee program that would see drugmakers seeking approval to market biosimilars in the US initially paying fees similar to those required of originator biologic drug developers [1].

In Europe, a system of biosimilar fees already exists for the EMA, with the fee for a biosimilar being around 64% of the fee for a new biological, reflecting the lower workload. Prior to filing, no fees other than the optional Scientific Advice fee are charged. This fee is identical for all products (chemical, biological, etc.). To the knowledge of the EGA, the EMA has completed 100% of its reviews of biosimilars within the target timeline of 210 days (excluding clock stops).

Recommendations from the FDA on the issue of biosimilar user fees are to be presented to Congress by 15 January 2012.

Editor’s comment

The debate over user fees for biosimilars is certainly not over. However, maybe more effort should be focussed on actually getting the guidelines in place for a practical pathway for approval first?

Please feel free to share your thoughts via email to editorial@gabionline.net or in the comments section below. What are your views on user fees for biosimilars in the US? How do you think this will affect the biosimilars industry?

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Biosimilars user fees as high as brand-name fees

Reference

1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars user fees as high as brand-name fees [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 June 23]. Available from: www.gabionline.net/Biosimilars/News/Biosimilars-user-fees-as-high-as-brand-name-fees