Drugs

Lilly Forteo Petition Denied

David McFarland

— 2 min read
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FDA has denied an 8/18/16 Lilly petition asking that it open notice and comment rulemaking to revise the regulatory definition of “biological product” such that Forteo (teriparatide [rDNA origin] injection) would fall within the statutory definition under the Biologics Price Competition and Innovation Act. Specifically, the petition asked that FDA: 

  •          refuse to approve any ANDA that cites Forteo as the reference-listed drug (RLD), including one submitted by Teva;
  •          require that any section 505(b)(2) application or future biosimilar application citing Forteo as the RLD or reference product demonstrate that the proposed follow-on product is highly similar to, and has no clinically meaningful differences from, Forteo, in terms of safety and effectiveness, based on data derived from analytical studies, bioassay, comparative clinical immunogenicity testing, comparative clinical pharmacokinetic and pharmacodynamic studies, and other studies described in the petition;
  •          determine that a follow-on teriparatide product may not be deemed therapeutically equivalent to Forteo or, alternatively, if FDA determines that therapeutic equivalence determinations with respect to Forteo are scientifically feasible, refrain from issuing such a therapeutic equivalence determination unless the applicant provides the clinical switching and alternating data described in the petition;
  •          initiate notice and comment rulemaking to review the regulatory definition of “biological product” to align with the statutory definition in the Public Health Service Act and scientific understanding of the term “protein”; and
  •          upon 3/23/20 deem the NDA for Forteo to be a BLA for regulatory approval purposes and require follow-on applications to proceed under section 351(k) at that time.

The agency denial letter rejects the first, second, third, and fifth requests without commenting on the approvability of an ANDA or 505(b)(2) teriparatide product referencing Forteo as it would be premature to do so. To the extent that Lilly is asking in its fourth request for notice and comment rulemaking, the letter says, that also is denied, with the note that FDA intends to initiate such rulemaking consistent with its priorities and resources and cannot comment on whether it would propose to revise the regulations in the manner that Lilly requests.

“We invite Lilly and other stakeholders to submit comments to the docket that would be established for such rulemaking,” it says. It also invites comments on a draft guidance on submission of ANDAs for certain highly purified synthetic peptide drug products that reference peptide drug products of rDNA origin.

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