FDA Denies Novo Nordisk Petition on Liraglutide Generics
Posted 08 January 2018 | By
The US Food and Drug Administration (FDA) on Friday denied Novo Nordisk’s citizen petition that aimed to block generic versions of its blockbuster insulin Victoza (liraglutide) and two other products containing liraglutide.
Novo argued that the Type 2 diabetes drugs containing liraglutide are large and complex molecules and that a manufacturing process that differs from its own might have unintended consequences. The company also argued that FDA has not issued guidance on qualification levels for certain impurities.
However, in FDA’s letter denying the petition, the agency pointed to its October draft guidance to assist potential applicants in determining when a synthetic peptide that refers to a previously approved peptide of recombinant DNA (rDNA) origin should be submitted as an abbreviated new drug application (ANDA) or 505(b)(2) applications.
"The draft guidance, if finalized as written, would cover five peptide drug products, including liraglutide," FDA said while encouraging Novo to submit comments on the draft.
"FDA intends to consider issues related to generic synthetic peptides that reference peptides of rDNA origin as the RLDs [reference listed drugs] and generic peptides of rDNA origin in the context of the public docket opened for comment on the draft guidance. The Agency declines to address these issues in this petition response because to do so would be premature," the letter said.
Novo Nordisk told Focus in a statement: "We’re aware that the U.S. Food and Drug Administration (FDA)
denied our 2017 citizen’s petition requesting FDA not to approve follow-on
medicines to liraglutide through an ANDA application. Novo Nordisk is
committed to the safety of patients relying on important medications to treat
their disease. We’re also committed to continuing to work with the FDA as
the agency works on its recently published draft guidance on its
abbreviated new drug application (ANDA) process for synthetic peptides.
It’s important to know that this denial does not automatically mean the
FDA will approve ANDA’s involving liraglutide.
"The FDA asked Novo Nordisk for comments from the company
pertaining to the agency’s review of peptide products under its ANDA process,
and we already submitted feedback in December 2017. We look forward to
further engaging with the FDA, and hope they reconsider their draft guidance.”
The denial of Novo’s petition comes as Teva last February said it has filed an ANDA and believes it could be first to market the generic version of Victoza, which brought in about $3.2 billion in 2016 sales.
Editor's note: Article updated 1/11/17 with comment from Novo Nordisk.