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Regulatory Focus™ > News Articles > 2019 > 7 > Updated: Why Isn’t Insulin a Complex Generic? PA Representative Asks FDA

Updated: Why Isn’t Insulin a Complex Generic? PA Representative Asks FDA

Posted 23 July 2019 | By Zachary Brennan 

Updated: Why Isn’t Insulin a Complex Generic? PA Representative Asks FDA

Rep. Mike Kelly (R-PA) sent a letter Tuesday to US Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless questioning why insulin, which has seen dramatic price increases, is not considered a complex generic drug.

Follow-on insulin developers have historically not chosed to pursue an abbreviated new drug application (ANDA) to win approval for a copycat product, but have gone the route of a 505(b)(2) application, which only partly relies on the reference product. And coming next March, any follow-on insulin products will need to be approved as biosimilars.

Kelly points to an October 2017 FDA draft guidance on ANDAs for certain peptide products, questioning why insulin was not included in the guidance and wondering if there are “safety, efficacy or statutory barriers to its inclusion.”

The draft says: "FDA considers any polymer composed of 40 or fewer amino acids to be a peptide regulated under the FD&C Act, rather than a protein regulated under the Public Health Service Act.” But insulin is 51 amino acids. 

“If the exclusion of insulin from the 2017 guidance was due to statutory limitations, what legislative action is required to remove such obstacles?” the Pennsylvania representative asks.

But former FDA Commissioner Scott Gottlieb explained: "Insulin is a biologic but was historically regulated as a drug; one of 4 biologics to fall under the FDCA. While many applicants chose to file 505(b)(2) copies, the ANDA path was always open. But the biosimilar route should provide more robust path for copies."

He added: "So the question of why insulin 'isn’t regulated as a complex generic' is moot - insulin was always regulated as a drug under the FDCA and eligible for generic competition from ANDA applicants. The barriers to generic entrants were largely commercial and technical, not statutory."

Meanwhile, FDA held a public meeting in May on biosimilar and interchangeable insulins, noting how competition is currently limited to only three follow-on insulin products—Basaglar, Lusduna and Admelog—which have been approved since 2015. But interchangeable insulins are expected. And several senators in March called on FDA to tweak other guidance to speed up the marketing of new biosimilar insulin products. Insulin manufacturers, however, told a House committee in April that simply lowering the list price for insulin will not increase access.

Regardless, the cost of insulin in the US continues to rise. Rep. Kelly notes that the average annual cost of insulin for a person with type 1 diabetes is $5,705, a 600% increase since 2001. Americans have been caravanning to Canada to obtain insulin supplies in recent years, and a recent Bernstein Research report found that the price of insulin in the US is between three and five times higher than countries in Europe, Asia and Latin America.

Updated on 7/23/19 with comments from former FDA Commissioner Scott Gottlieb.


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