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Unlike with generic drugs of the more common small-molecule type, biosimilar drugs generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes. Despite this heterogeneity, all biopharmaceuticals , including biosimilars, must maintain consistent quality and clinical performance throughout their ...
When used as drugs, the International Nonproprietary Names (INNs) end in -mab. The remaining syllables of the INNs, as well as the column Source, are explained in Nomenclature of monoclonal antibodies. Types of monoclonal antibodies with other structures than naturally occurring antibodies.
Tremelimumab, sold under the brand name Imjudo, is a fully human monoclonal antibody used for the treatment of hepatocellular carcinoma (a type of liver cancer). [7] [8] Tremelimumab is designed to attach to and block CTLA-4, a protein that controls the activity of T cells, which are part of the immune system (the body’s natural defenses).
Anti-drug antibodies can cause negative side effects, accelerate the rate of drug clearance, and reduce the therapeutic effects of the biologic. [23] In clinical practice, less than 50% of patients who showed an initial positive response to biological therapy were in remission after one year. [10]
Common side effects include infections, acute infusion reactions, and abdominal pain. [23] 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.
The agency approved Biocon Biologics' Yesafili as well as Samsung Bioepis and Biogen's Opuviz, while also allowing interchangeability, or the drug's substitution with biosimilars without the need ...
The most common side effects reported by the European Medicines Agency (EMA) include injection-site reactions (such as redness, swelling including due to fluid build-up, itching and pain), conjunctivitis (redness and discomfort in the eye) including conjunctivitis due to allergy, joint pain, cold sores, and increased blood levels of a type of ...
Clinical studies have shown that the most common side effect is a slight reaction at the site of injection in the form of redness, and sometimes swelling. [4] Clinical studies have shown that, one hour after injection, the incidence of at least one moderate or severe local skin reaction per treatment cycle was 12% in 4 patients treated with ganirelix and 25% in patients treated subcutaneously ...