Although insulin is a peptide, it is currently regulated under the Food Drug and Cosmetic Act (FD&C), limiting the options for companies that want to bring off-patent versions to market.
Those options are set to change in March 2020 when the 10-year transition of insulin to a biologics designation comes to an end.
Once the transition is over, companies will be able to file for US Food and Drug Administration (FDA) approval of insulin biosimilars, which pharmacists can substitute for their branded equivalents.
In preparation for the change, the FDA held a public hearing on the future of biosimilar insulin. Ned Sharpless, acting FDA commissioner, used his speech at the event to criticise price increases on the products, such as the 585% increase in the price of insulin lispro between 2001 and 2015
“It hardly needs to be said that these kinds of whopping and steady price increases make it increasingly difficult for many insulin-dependent patients to afford the basic medicines they need to survive. As a physician, I find this intolerable: no patient should have to choose between paying for their medicine and paying for their rent,” Sharpless said.
Sharpless cited the Congressional Research Service’s identification of the 585% rise in the price of insulin lispro, sold by Eli Lilly as Humalog, and a Schaefer Center study showing double-digit annual increases in four insulin categories to illustrate the problem.
Following the playbook of his predecessor, Scott Gottlieb, Sharpless wants to use the FDA’s power to increase market competition to make insulin products more affordable.
The expectation is that the finalisation of FDA guidance permitting the pharmacy-level substitution of biosimilars and the change in the status of insulin products will usher in an era of fierce competition, resulting in lower prices for consumers.
The biosimilar insulin pipeline
For that vision to come to pass, companies will need to develop biosimilar insulin products to the standard needed to be deemed interchangeable with their reference products.
It is questionable whether that will happen in the near term. While Sharpless said “there is already a great deal of interest among potential sponsors,” the pipeline of biosimilar insulin prospects is fairly barren.
Merck, known as MSD in North America, and Samsung Bioepis stopped development of a copy of Sanofi’s Lantus last year, after assessing whether the pricing environment and manufacturing costs justified further investment.
Mylan and Biocon have a copy of Lantus that they hoped to bring to market under the current FD&C pathway, but a patent dispute has stymied their progress.
Lilly and Sanofi won approval for copies of each other’s drugs under the existing pathway, which treats the products as non-substitutable follow-on biologics, but current pipelines suggest it may be some time before rivals seize the opportunity created by the FDA’s guidance on interchangeability.