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BIO Comments on FDA Draft Guidance ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin

Re: Docket No. FDA-2017-D-5767-0022: ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin

Dear Sir/Madam:

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance titled “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin”.

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.

BIO supports FDA’s initiative to provide enhanced regulatory guidance on considerations for approval of generic and follow-on medicine products. In particular and as stated in the guidance,[1] we support FDA’s recognition that when clinical studies are necessary for regulatory assessment of generic medicines and follow-on peptide products a 505(b)(2) application is the appropriate regulatory pathway for application submissions. However, BIO requests FDA provide greater scientific reasoning and specificity on its analysis for the sweeping determination within this guidance that an ANDA submission may be appropriate for the five specific peptides referenced in this Draft Guidance.[2]

BIO has made the following comments with respect to this Draft Guidance which are addressed in more detail below:

  1. The Draft Guidance treats the regulatory assessment of these five polypeptides differently from biological products, which as communicated in previous comments is of concern to BIO.[3]
  2. The Draft Guidance lacks support for the arguments that “sameness” of active ingredient for peptide products can be demonstrated without clinical comparative data.
  3. The scope of the title does not align with the scientific support and potential approval for peptide products through an ANDA submission.
  4. The Draft Guidance does not provide sufficient scientific justification for FDA’s acceptance and identification thresholds that it has selected for peptide-related impurities.
 

[1] See Draft Guidance line 8 (“If it is necessary to conduct clinical studies to establish the safety or effectiveness of a proposed synthetic peptide that seeks to rely, in part, on FDA’s finding of safety or effectiveness for a previously approved product, submission of an application under the abbreviated pathway described in section 505(b)(2) of the FD&C Act would be necessary.”).

[2] See id. at Lines 19-20.

[3] See BIO comments to Docket No. FDA–2011-D-0611 and Docket No. FDA-2015-D-4750 (May 13, 2016).