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The FDA has generally recommended switching studies to show evidence of interchangeability of a biosimilar. Regulatory reform is needed so patients can more easily access biosimilars and draw ...
Biosimilar is a term used to describe a biopharmaceutical product which seems so close in composition and effect to another that they are functionally identical, analogous to generic drugs. In this context, some publications describe "biologics" as "biosimilars". [26]
Infliximab is a chimeric monoclonal antibody biologic. It seems to work by binding to and neutralizing TNF-α, preventing it from interacting with its receptors on the cell. [23] TNF-α is a chemical messenger and a key part of the autoimmune reaction. Infliximab was originally developed in mice as a mouse antibody.
The first biosimilar of a monoclonal antibody to be approved worldwide was a biosimilar of infliximab in the EU in 2013. [9] On March 6, 2015, the FDA approved the United States' first biosimilar product, the biosimilar of filgrastim called filgrastim-sndz (trade name Zarxio) by Sandoz .
Insulin aspart, sold under the brand name Novolog, among others, is a modified type of medical insulin used to treat type 1 and type 2 diabetes. [18] It is generally used by injection under the skin (into the abdomen, buttocks, thighs, or upper arms) but may also be used by injection into a vein. [18]
The anti-TNF-α monoclonal antibody infliximab is a major biological therapy for inflammatory bowel diseaseBiological therapy, the use of medications called biopharmaceuticals or biologics that are tailored to specifically target an immune or genetic mediator of disease, plays a major role in the treatment of inflammatory bowel disease. [1]
An insulin analog (also called an insulin analogue) is any of several types of medical insulin that are altered forms of the hormone insulin, different from any occurring in nature, but still available to the human body for performing the same action as human insulin in terms of controlling blood glucose levels in diabetes.
It is not typically the recommended long-acting insulin in the United Kingdom. [8] Semglee is indicated to improve glycemic control in adults and children with type 1 diabetes and in adults with type 2 diabetes. [12] Semglee is both biosimilar to, and interchangeable with its reference product Lantus (insulin glargine), a long-acting insulin ...