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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".
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 ...
Infliximab was approved for medical use in the United States in 1998, [23] and in the European Union in August 1999. [19] Infliximab biosimilars have been approved in the EU (2013), in Japan (2014), and in the United States (2016, 2017, 2019). [1] [4] [2] It is on the World Health Organization's List of Essential Medicines. [25]
Instead there are biosimilars. Biosimilars are defined by the FDA as, "a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product." [28] Currently, the only two biologic treatments for IBD that have approved biosimilars are adalimumab and infliximab. [11]
Physicians are cautioned to avoid switching patients from branded to generic, or between different generic manufacturers, when prescribing anti-epileptic drugs, warfarin, and levothyroxine. [ 11 ] Major issues were raised in the verification of bioequivalence when multiple generic versions of FDA-approved generic drug were found not to be ...
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.
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 ...
The BPCI Act is closely related to the Drug Price Competition and Patent Term Restoration Act of 1984 (or referred to as the "Hatch-Waxman Act"), which established abbreviated pathways for the approval of drug products under the Federal Food, Drug, and Cosmetic Act (FD&C Act). [1] [2]