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FDA seeks input on biosimilars user fees

The US Food and Drug Administration is seeking written comments from stakeholders and the public on the agency's efforts to develop a user fee programme for biosimilars

The US Food and Drug Administration (FDA) is seeking written comments from stakeholders and the public on the agency's efforts to develop a user fee programme for biosimilars, which are defined as biological products that are demonstrated to be highly similar to, or interchangeable with, an FDA-licensed biological product.

User fees, which are already in effect for drugs and biologics, are fees from companies that are used to expedite the process of reviewing marketing applications. The FDA's efforts on developing a user fee system for biosimilars are based on the Biologics Price Competition and Innovation (BPCI) Act of 2009, the legislation that is intended to create a regulatory pathway for abbreviated approvals of generic biological products.

The BPCI Act, which is part of the healthcare reform package that was signed into law by President Barack Obama last year, will create an abbreviated approval pathway for biosimilars along the lines of the application process that exists for generic drugs, which allows generic manufacturers to rely on data that has already been gathered about a drug rather than duplicating trials.

BPCI directs the FDA to develop recommendations for a biosimilars user fee programme for fiscal years 2013 through 2017. The recommendations must be presented to Congress by January 15, 2012.

The FDA said that, in addition to reviewing the written comments, it will consult with a range of groups, including scientific and academic experts, healthcare professionals, representatives of patient and consumer advocacy groups, and regulated industry. The agency will then develop proposed recommendations that will be published for public comment, presented to Congressional committee staff, and presented at a public meeting.

17th May 2011

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