FDA News

FDA denies Amneal request to block approvals of generic Forteo

The FDA has rejected Amneal Pharmaceuticals’ citizen petition to refrain from approving any abbreviated new drug applications for generic versions of teriparatide as treatment for osteoporosis.

The company, which markets teriparatide under the brand name Forteo, requested a stay of approval for abbreviated new drug applications (ANDA) for generics that “contain synthetically derived teriparatide active substance” and asked the agency to “only approve ANDAs for teriparatide injection products that contain recombinant human parathyroid hormone.”

In its citizen petition, Amneal also argued that the “synthetic peptide must not be accepted as a generic equivalent of a [recombinant] DNA-derived peptide” as synthetic versions of the teriparatide injection could not fulfill the labeling requirements for ANDAs. Amneal maintained that, due to the recombinant manufacturing process, it would be “impossible for a synthetically derived generic teriparatide to have impurity, aggregate and leachate profiles comparable to the recombinantly derived Forteo.”

In the FDA’s denial of the petition, the agency referenced recently issued draft guidance for the application of synthetic peptide products, which noted that ANDA submission for a generic synthetic peptide is acceptable provided that:

  • The level of each peptide-related impurity in the proposed generic synthetic peptide is the same as or lower than that found in the reference;
  • The proposed generic synthetic peptide does not contain any new peptide-related impurity that is more than 0.5% of the drug substance;
  • Each new specified peptide-related impurity is characterized; and
  • Applicants explain why each new specified peptide-related impurity does not impact the safety/efficacy of the proposed generic synthetic peptide.

“We are continuing to consider the circumstances under which an application for a generic synthetic peptide that relies upon a peptide of recombinant DNA origin should be submitted as an ANDA under section 505(j) of the Food, Drug and Cosmetic Act,” the FDA stated. “FDA intends to consider issues related to generic synthetic peptides that reference peptides of recombinant DNA origin as the [reference drug] and generic peptides of recombinant DNA origin in the context of the public docket opened for comment on the draft guidance.”

The FDA has rejected Amneal Pharmaceuticals’ citizen petition to refrain from approving any abbreviated new drug applications for generic versions of teriparatide as treatment for osteoporosis.

The company, which markets teriparatide under the brand name Forteo, requested a stay of approval for abbreviated new drug applications (ANDA) for generics that “contain synthetically derived teriparatide active substance” and asked the agency to “only approve ANDAs for teriparatide injection products that contain recombinant human parathyroid hormone.”

In its citizen petition, Amneal also argued that the “synthetic peptide must not be accepted as a generic equivalent of a [recombinant] DNA-derived peptide” as synthetic versions of the teriparatide injection could not fulfill the labeling requirements for ANDAs. Amneal maintained that, due to the recombinant manufacturing process, it would be “impossible for a synthetically derived generic teriparatide to have impurity, aggregate and leachate profiles comparable to the recombinantly derived Forteo.”

In the FDA’s denial of the petition, the agency referenced recently issued draft guidance for the application of synthetic peptide products, which noted that ANDA submission for a generic synthetic peptide is acceptable provided that:

  • The level of each peptide-related impurity in the proposed generic synthetic peptide is the same as or lower than that found in the reference;
  • The proposed generic synthetic peptide does not contain any new peptide-related impurity that is more than 0.5% of the drug substance;
  • Each new specified peptide-related impurity is characterized; and
  • Applicants explain why each new specified peptide-related impurity does not impact the safety/efficacy of the proposed generic synthetic peptide.

“We are continuing to consider the circumstances under which an application for a generic synthetic peptide that relies upon a peptide of recombinant DNA origin should be submitted as an ANDA under section 505(j) of the Food, Drug and Cosmetic Act,” the FDA stated. “FDA intends to consider issues related to generic synthetic peptides that reference peptides of recombinant DNA origin as the [reference drug] and generic peptides of recombinant DNA origin in the context of the public docket opened for comment on the draft guidance.”