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U.S. Department of Health and Human Services

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Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009: Questions and Answers Part III

 
Table of Contents 
 
Part III.        EXCLUSIVITY
 
Q.III.1.  
Q.III.2.How can a prospective biosimilar applicant determine whether there is unexpired orphan exclusivity for an indication for which the reference product is licensed?
  
  
Q.III.1. Can an applicant include in its 351(a) BLA submission a request for reference product exclusivity under section 351(k)(7) of the PHS Act?
A.III.1.(Proposed Answer): Yes. FDA is continuing to review the reference product exclusivity provisions of section 351(k)(7) of the PHS Act and has requested public comment on factors to consider in FDA’s interpretation of certain statutory provisions (see Docket No. FDA-2010-N-0477). An applicant may include in its BLA submission a request for reference product exclusivity under section 351(k)(7) of the PHS Act, and FDA will consider the applicant’s assertions regarding the eligibility of its proposed product for exclusivity. At this time, FDA suggests that an applicant’s request for reference product exclusivity specifically describe how the proposed product meets the statutory requirements in section 351(k)(7) of the PHS Act, and include adequate data and information to support the request.
  
Q.III.2.How can a prospective biosimilar applicant determine whether there is unexpired orphan exclusivity for an indication for which the reference product is licensed?
A.III.2.(Proposed Answer): A searchable database for Orphan Designated and/or Approved Products and indications is available on FDA’s Web site, and is updated on a monthly basis (see http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm). FDA will not approve a subsequent application for the “same drug” for the same indication during the 7-year period of orphan exclusivity, except as otherwise provided in the FD&C Act and 21 CFR part 316.