Biocon Biologics has announced a new agreement with Civica Inc., “to expand patient access and affordability to insulin aspart in the US.”
India-based Biocon Biologics does not currently have an approved insulin aspart biosimilar in the US, but it is approved in Canada. The company is pursuing its own insulin aspart biosimilar in the US, but it received a complete response letter from the FDA in 2023, related to pre-approval plant inspection deficiencies. The facility inspection was completed in September 2024, according to a spokesman for the manufacturer.
Civica is a nonprofit generic drug and pharmaceutical company, that was founded to expand access and affordability of low-cost medicines in the United States. It primarily serves as a supplier of generic drugs, with a focus on drugs subject to shortage, to hospitals and health systems. Insulin has long been a manufacturing target of the company.
According to Matthew Erick, Chief Commercial Officer, Advanced Markets, Biocon Biologics is “providing drug substance (raw ingredients) to Civica, and this is not a branded Biocon Biologics product.” Mr. Erick told BR&R in an interview, “it will be up to Civica to produce their own aspart biosimilar from the ingredients.” That also implies obtaining FDA approval for the biosimilar, and then selling and distributing it.
“The arrangement makes sense,” said Mr. Erick, “because the missions of the two organizations are aligned. It just provides broader access to the lower-priced insulin. There is no commercial agreement between the two companies. Not many biosimilar companies can do this,” he stated. “We’re very proud of this arrangement.” Mr. Erick noted that Biocon still intends to market its own biosimilar insulin aspart in the US once it gains FDA approval.
This seems to represent an expansion by Biocon, but the company emphasized that this is not a private-label arrangement. Instead, the press release termed it a “strategic manufacturing collaboration.”
According to Ned McCoy, President and CEO of Civica, Inc., “Our partnership with Biocon Biologics for aspart drug substance supply will allow us to deliver on our important mission and help people who need access to insulin aspart. Civica will utilize our US-based manufacturing operations in Petersburg, Virginia, to produce prefilled pens and vials of insulin.”
The first biosimilar insulin aspart to receive FDA approval was Merilog by Sanofi Aventis in mid-February.
(Editor’s note: This post was modified March 10 with a corrected image of Matthew Erick.)
