Meitheal Pharmaceuticals Announces FDA Approval of Garzulys (insulin aspart-fsan) Injection, Making It the 3rd Insulin Aspart Biosimilar Approved in 2026

On July 24, 2026, there was news that Chicago-based Meitheal Pharmaceuticals had received FDA approval for another (the third approved in 2026) of Novo Nordisk's Novolog prandial insulin analogue which will be branded as Garzulys. Observe that on February 14, 2025, FDA approved Sanofi's biosimilar of Novolog branded as Merilog, and then on July 15, 2025, FDA subsequently approved Biocon Biologics copy of Novolog branded as Kirsty. Collectively, with the approval of Garzulys, the FDA has (as I write this in 2026) approved three (3) biosimilar copies of insulin aspart.

The FDA approval letter for Garzulys (insulin aspart-fsan) 100 units/mL can be viewed at for https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761497Orig1s000ltr.pdf while the company issued a press release indicating that its biosimilar copy of insulin aspart on July 30, 2026. The press release can be viewed at https://www.businesswire.com/news/home/20260730232521/en/Meitheal-Pharmaceuticals-Announces-FDA-Approval-of-Garzulys-insulin-aspart-fsan-Injection/. 

Observe that I do believe that Emerge Bioscience Pte Ltd. is a unit of China-based Tonghua Dongbao Pharmaceutical Co., Ltd., which actually holds the approved U.S. biologics license application for Garzulys, while Meitheal Pharmaceuticals serves as the product's U.S. regulatory agent and holds exclusive U.S. commercialization rights under a license agreement with Emerge. Emerge is the U.S. BLA holder and is responsible for key supply-chain activities associated with the product. Also know that back on September 21, 2023, Meitheal Pharmaceuticals announced its intention to sell biosimilars not only of Novolog, but also of Humalog and Lantus (catch my coverage of that announcement at https://blog.sstrumello.com/2023/09/another-three-biosimilar-insulins.html for more). So far, Garzulys has become its first of three. We anticipate seeing others in the not-too-distant future.

The Meitheal Pharmaceuticals press release stated:

"The FDA approval of Garzulys represents an important milestone in Meitheal's continued expansion beyond our established generic injectable business and into a broader portfolio of biologics and branded products," said Tom Shea, Chief Executive Officer of Meitheal. 

"We are making deliberate, long-term investments in the regulatory expertise, commercial infrastructure and strategic partnerships needed to expand patient access to high-quality biologic treatment options. Our leadership of the U.S. regulatory process for Garzulys demonstrates the strength of our platform and the disciplined execution we bring to complex products and global partnerships."

We do know that Garzulys will be sold in internationally-standardized 10 mL vials, as well as in prefilled insulin pen devices. While it is unclear what retail price will be for either, or whether Meitheal Pharmaceuticals intends to sell the product to PBMs, direct-to-patients, as private (white) label products sold under retail pharmacy partner brands, or some combination of these.

However, we do know that another biosimilar company, Sandoz, on July 2, 2026 announced a direct-to-patient model known as Sandoz Direct https://www.sandozdirect.com/, similar to Lilly's Lilly Direct platform which sells Lilly insulin products at prices vastly lower than are available elsewhere. Sandoz Direct is powered by Aalto Pharmacy The direct-to-patient models work to enable patients to bypass insurance company and PBM rebate markups, and have proven to be a valuable affordability work-around to the dysfunctional U.S. prescription drug distribution system. It is unclear whether Meitheal Pharmaceuticals will offer a direct-to-patient business model as Sandoz and Lilly now do.