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FDA releases draft guidance on reference product exclusivity for biologicals Posted 22/08/2014

The US Food and Drug Administration (FDA) has issued new draft guidance concerning biosimilars. The draft guidance, issued on 5 August 2014, is intended to assist sponsors in determining the date of first licensure for a reference product.

The date of first licensure is important as it will determine when a biosimilar manufacturer can submit an application to FDA via the abbreviated biosimilars pathway, which was brought into law as part of the US Biologics Price Competition and Innovation (BPCI) Act of 2009.

The guidance makes it clear that originator biologicals will enjoy a period of 12 years of marketing exclusivity on their products from the date of first licensure. Before the end of this period FDA approval of a biosimilar application ‘may not be made effective’. However, biosimilar applications may be submitted to FDA once four years from the date of first licensure have passed.

Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act
Date: August 2014
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM407844.pdf

The agency goes on to point out that originator companies will gain an additional six-month period of exclusivity (in which a biosimilar or interchangeable biological product cannot be licensed or accepted for review) over and above the 12- and 4-year periods, respectively, if the sponsor conducts paediatric studies.

The guidance sets forth the date of first licensure to be ‘the initial date the particular product at issue was licensed in the United States’, with some exceptions (including changes resulting in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength; or modifications to the structure of the biological).

The guidance proposes the type of information required in order to determine the date of first licensure. This includes:

  1. A list of all licensed biological products that are structurally related to the biological product.
  2. A list of the current or previous license holder.
  3. Description of the structural differences between the proposed product and the licensed biological products, e.g. changes in amino acid sequence, differences in glycosylation patterns or tertiary structure and differences in biological activities.
  4. Evidence of any change in safety, purity and/or potency between the proposed product and the licensed biological products.

FDA states that it is ‘reviewing options for making information publicly available regarding reference product exclusivity and dates of first licensure.’ The agency adds that once a method is determined, it plans to communicate this information on the agency’s website.

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Source: FDA

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