- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Vizient Says It Supports FDA Plan for Insulin Biosimilars, Interchangeable Insulins
The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.
Vizient said this week it endorses the FDA’s draft guidance for industry on clinical immunogenicity considerations for biosimilar insulins and interchangeable insulins.
The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.
In March, insulins will be regulated as biologics, and as such, developers will be able to seek licensure for subsequent-entry insulins under the biosimilar approval pathway after that time, whereas they are currently treated as follow-ons.
In a statement, Vizient said it believes FDA’s the guidance will support a more effective and efficient approval process by streamlining clinical data requirements.
“Vizient fully supports scientifically justified opportunities to improve approval processes for biosimilars and interchangeable biologics, including insulins,” Steven Lucio, Vizient’s vice president, pharmacy solutions, said in a statement.
“The approval of more insulin biosimilars will enable patients with diabetes to have much needed access to more affordable treatment options,” he added; the change will create more competion and lower healthcare spending.
In its comment on the draft, Vizient wrote that the FDA's approach is justified "given the strength of analytical characterization data, the less complex structure of insulin, and the absence of a clinical impact of immunogenicity with insulin use."
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Aflibercept Biosimilar MYL-1701P Provides Equivalence in DME Therapy
November 27th 2024The study findings demonstrate that the aflibercept biosimilar MYL-1701P is as effective and safe as the reference aflibercept in treating diabetic macular edema (DME), offering a promising option for reducing treatment costs and improving global access to care for patients with DME.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Overcoming Challenges to Improve Access and Reduce Costs
November 12th 2024Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.
