Two biosimilars—Zimrixby (rituximab-cdxx) and Garzulys (insulin aspart-fsan)—received US Food and Drug Administration (FDA) approval in July 2026, expanding treatment options in oncology, immunology and diabetes care.
Zimrixby (rituximab-cdxx)
The FDA approved Zimrixby (rituximab-cdxx), a biosimilar to Rituxan (rituximab), in July 2026. The product was developed, manufactured and submitted for regulatory approval by Dr Reddy’s Laboratories. Under an exclusive commercialization agreement, Fresenius Kabi—an operating company of the Fresenius Group—holds exclusive rights to market and commercialize the biosimilar in the US.
Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders [1].
The FDA's approval decision was based on the totality-of-the-evidence approach, the standard regulatory framework for evaluating biosimilars. This comprehensive data package demonstrated that Zimrixby is highly similar to the reference product, Rituxan, with no clinically meaningful differences in safety, purity, or potency.
Currently, there is a total of four rituximab biosimilars approved in the US, including Zimrixby and:
- Truxima (rituximab-abbs) by Celltrion/Teva, approved in November 2018 [2]
- Ruxience (rituximab-pvvr) by Pfizer, approved on 23 July 2019 [3]
- Riabni (rituximab-arrx) by Amgen, approved in December 2020 [4].
Garzulys (insulin aspart-fsan)
The FDA approved Garzulys (insulin aspart-fsan) on 24 July 2026. The product is commercialized by Meitheal Pharmaceuticals, Inc, which holds exclusive US commercialization rights under a license agreement with the BLA holder, Emerge Bioscience.
The biosimilar was developed through a collaboration in which Tonghua Dongbao was responsible for drug substance development, Nanjing King-Friend (NKF) was responsible for drug product development, and Xentria led the clinical development programme.
Garzulys is a rapid-acting human insulin analog biosimilar to NovoLog (insulin aspart), indicated to improve glycaemic control in adult and paediatric patients with diabetes mellitus. The FDA has approved Garzulys formulations for both subcutaneous and intravenous administration. It is available as a 100 units/mL (U-100) injection in 10 mL multiple-dose vials and 3 mL single-patient-use prefilled pens.
The FDA's approval decision was similarly based on a comprehensive data package demonstrating that Garzulys is highly similar to its reference product, NovoLog, with no clinically meaningful differences in safety, purity, or potency. This determination was supported by the totality-of-the-evidence approach, including analytical, non-clinical and clinical data that confirmed the biosimilar's comparability to the reference biological.
Garzulys is the third insulin aspart biosimilar approved in the US, following Kirsty (insulin aspart-xjhz) by Biocon [5], approved in July 2025 which also became the first interchangeable biosimilar insulin aspart, and Merilog (insulin aspart-szjj) by Sanofi-Aventis [6], approved in February 2025.
Significance
The July 2026 approvals add to the growing US biosimilars landscape. Zimrixby joins existing rituximab biosimilars including Truxima (rituximab-abbs), which received interchangeability status on 1 July 2026, Ruxience (rituximab-pvvr) and Riabni (rituximab-arrx). Reported US hospital biosimilar utilization reached 84% for rituximab by 2024.
Garzulys expands the rapidly growing insulin biosimilar market, providing additional treatment options for the approximately 38 million Americans living with diabetes.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of rituximab [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 2]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-rituximab
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves first rituximab biosimilar Truxima [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 2]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-first-rituximab-biosimilar-Truxima
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves rituximab biosimilar Ruxience [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 2]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-rituximab-biosimilar-Ruxience
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves rituximab biosimilar Riabni [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 2]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-rituximab-biosimilar-Riabni
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable rapid-acting insulin biosimilar, Kirsty [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 2]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-rapid-acting-insulin-biosimilar-kirsty
6. GaBI Online - Generics and Biosimilars Initiative. Insulin aspart and denosumab biosimilars approved in US [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 2]. Available from: www.gabionline.net/biosimilars/news/insulin-aspart-and-denosumab-biosimilars-approved-in-us
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