Under the proposed user fee programme, which would cover 2013 to 2017, the agency plans to break down the cost to review biosimilars into separate payments. More money would be charged up front during development, and subsequent fees would then be assessed annually. These charges would be followed by the same application, establishment and product fees required for all drugs.

The proposal is open to comments from the public until 9 June 2011. During which time the agency also plans to consult with a range of groups, including scientific and academic experts, healthcare professionals and representatives of patient and consumer advocacy groups.

The FDA says that it will take this input into account in developing the proposed recommendations. These will then be published in the Federal Register for public comment, and presented to Congress. The agency also intends to present the recommendations at a public meeting.

‘Given that the approval pathway for biosimilar and interchangeable biological products is new, FDA services are most critical for continued and successful development of biosimilar and interchangeable biological products during the investigational stage prior to submission of a marketing application,’ the agency said in its Federal Register notice.

The Patient Protection and Affordable Care Act (amended by the Health Care and Education Reconciliation Act), which made possible a pathway for biosimilars in the US, was signed into law on 23 March 2010 by President Barack Obama. Despite this fact, the US is still some way behind the EU, which has clear guidelines in place for biosimilars, and approved its first biosimilar back in 2006.

There is much to gain by accelerating the procedure. The Congressional Budget Office estimates that savings of US$25 billion over the next 10 years could be made by increasing access to lower-cost versions of biological medicines for cancer, arthritis and rare genetic diseases.

What happens next?

Comments on the FDA’s proposals from the public will be accepted until 9 June 2011. The recommendations from the FDA will then be presented to Congress by 15 January 2012.

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