There are no biosimilar versions of biologic products in the United States because this class of medicines was not included in the 1984 “Hatch-Waxman” legislation that regulates the generics pharmaceutical industry. At the time, these products were considered ‘too complex’ to regulate. But in...
TNF inhibitors are lab-manufactured biologic products that suppress inflammation by blocking the activity of tumornecrosisfactor-alpha (TNF-A), a protein (cytokine) that plays a central role in promoting persistent inflammation in autoimmune disorders. TNF-A is produced by immune cells such as phagoc...
Biologic therapies: Biologics are a class of medications that reduce inflammation in the intestine by targeting specificimmune systemresponses. There are two classes of biologic agents used to control inflammation: Tumor necrosis factor(TNF) inhibitors (also called anti-TNF drugs): TNF is a protein ...
has developed and refined internal procedures for evaluating, prior to the marketing of a drug, the potential for a proposed proprietary name (i.e., “brand name”) to cause or contribute to medication errors as part of the Center’s focus on the safe use of drug and therapeutic biologic ...
BiologicBiosimilarDrug traceabilityNonproprietary namePharmacovigilanceThe purpose of the present study was to investigate the traceability of adverse events (AEs) for branded and generic drugs with identical nonproprietary names and to consider potential implications for the traceability of AEs for branded ...
The Engineered Drug Delivery Initiative developed approaches for delivering challenging biologic medicines. This work assists impaired patients in self-administering protein-based therapeutics. "We took a holistic approach to solving the problem of how to administer viscous drugs to patients with limited ...
A dealer in salted or dried meats, pickles, sauces, etc., and in the materials used in pickling, salting, and preserving various kinds of food Hence drysalters usually sell a number of saline substances and miscellaneous drugs. drysaltery noun (n.) The articles kept by a drysalter; also...