- Amneal Pharmaceuticals LLC has lost out on a bid to prevent more generic versions of Eli Lilly & Co.'s Forteo from coming to market.
- The Food and Drug Administration rejected a citizen petition from Amneal, which asked the agency to approve Abbreviated New Drug Applications (ANDAs) for Forteo only if the products contained recombinant human parathyroid hormone and weren't created using synthetically derived teriparatide, the drug's active ingredient.
- Amneal's argument was that synthetic peptides couldn't be equivalent to recombinant peptides derived from DNA, and therefore wouldn't stack up to biosimilar labeling and impurity requirements. Yet in a Jan. 5 response letter, the FDA pointed to recently issued draft guidance that supposed it's fair to submit an ANDA for a proposed generic synthetic peptide so long as its impurity profile is well characterized and the same as or lower than that of the reference product.
FDA Commissioner Scott Gottlieb has made increasing market competition one of his initial goals since taking control of the agency last year.
To that end, the FDA is working to make the generic drug approval process less arduous. It's unsurprising, therefore, that the agency hasn't been too keen on drugmaker attempts to stifle generic products from advancing.
Just last week, regulators swatted away Allergan plc's third citizen petition to prevent copycat versions of Restasis (cyclosporine) from coming to market. The big pharma suggested in vitro testing couldn't properly show bioequivalence to its blockbuster eye drug, but the claims didn't gain any sympathy from the FDA.
A similar situation played out last spring, when the agency declined a citizen petition from Apotex Inc. for biosimilars to Amgen Inc.'s Neulasta (pegfilgrastim).
As for Amneal, the FDA contended that — if the generic drugmaker has such a problem with synthetic peptides subbing in for recombinant DNA-derived products — it should address the draft guidance.
"We are continuing to consider the circumstances under which an application for a generic synthetic peptide that relies upon a peptide of rDNA origin should be submitted as an ANDA under section 505(j) of the FD&C Act. We encourage Amneal to participate in FDA's guidance development process by reviewing the draft guidance and submitting any comments to the public docket number...," the agency wrote.
Forteo sales totaled $1.24 billion in the first nine months of 2017, up nearly 15% from the same period in 2016. There are already two biosimilar versions of the drug approved in Europe, while its formulation and related process patents expire in the U.S. in Dec. 2018. The drug's U.S. use patents expire in August 2019.