See the DrugPatentWatch profile for Uzedy
Uzedy is manufactured by Viatris [1]. Viatris is a global healthcare company formed in 2020 from the combination of Pfizer's Upjohn business and Mylan [1][2].
What is Uzedy used for?
Uzedy is a biosimilar to natalizumab, a medication used to treat relapsing forms of multiple sclerosis (MS) and Crohn's disease [3][4]. Multiple sclerosis is a chronic disease that affects the brain and spinal cord, leading to a wide range of potential symptoms [5]. Crohn's disease is a chronic inflammatory condition that affects the digestive tract [6].
How does Uzedy work?
Uzedy, like natalizumab, is a monoclonal antibody that works by blocking the movement of inflammatory cells across the blood-brain barrier and into the central nervous system [4][7]. This action helps to reduce inflammation and nerve damage associated with these conditions.
When did Uzedy become available?
Uzedy received approval from the U.S. Food and Drug Administration (FDA) in March 2023 [3].
Who else makes biosimilars for natalizumab?
Besides Uzedy, other biosimilars to natalizumab have been approved. For example, Tysabri is the reference product for which Uzedy is a biosimilar, and it is manufactured by Biogen [4][8]. Information on other specific biosimilar manufacturers can be found on resources like DrugPatentWatch.com [9].
What are the risks associated with Uzedy?
As with natalizumab, Uzedy carries a risk of progressive multifocal leukoencephalopathy (PML), a rare and serious brain infection that can lead to disability or death [3][7]. It also carries a risk of other opportunistic infections and hypersensitivity reactions [3]. Patients and healthcare providers are advised to carefully consider these risks [7].
What is the difference between a biosimilar and a biologic drug?
Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved biologic, known as the reference product [10]. They are not exact copies, but their molecular structure, biological activity, and efficacy are comparable [10]. Uzedy is a biosimilar to natalizumab [3][4].