FDA announced in the Federal Register of 28 January 2015 that the agency is soliciting comments on the information collection in an application for a proposed biosimilar product and an application for a supplement for a proposed interchangeable product.

FDA states in its Federal Register publication that the information submitted to meet the standard for interchangeability must show that:

1. the biological product is biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient; and
2. for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.

FDA also estimates that, based on the biosimilars applications it received during 2014, the time needed for a drug manufacturer to complete the biosimilar application process for a determination of biosimilarity or for interchangeability is 860 hours. The agency estimates that it will receive five biosimilar applications annually and that two of those will also require an assessment of interchangeability. It also expects biosimilars applicants to spent two hours annually on patent infringement notifications.

What happens next?
Comments and suggestions regarding this notice can be submitted to www.regulations.gov or to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. All comments and suggestions should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance, i.e. 28 January 2015.

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