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Specialty drugs, a recent classification of pharmaceuticals, are high-cost drugs that are often biologics. [ 7 ] [ 8 ] [ 9 ] The European Medicines Agency uses the term advanced therapy medicinal products (ATMPs) for medicines for human use that are "based on genes, cells, or tissue engineering", [ 10 ] including gene therapy medicines, somatic ...
The BPCI Act is similar, conceptually, to the Drug Price Competition and Patent Term Restoration Act of 1984 (also referred to as the "Hatch-Waxman Act") which created biological drug approval through the Federal Food, Drug, and Cosmetic Act (FFD&C Act).
The anti-TNF-α monoclonal antibody infliximab is a major biological therapy for inflammatory bowel disease. Biological 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]
Other drugs which may provide relief include acitretin, ciclosporin, and methotrexate, but since these drugs have their own major side effects, doctors and patients should discuss whether to try one of these or a biologic first. [4] Most biologics are injections so are not appropriate for use by someone with intense fear of needles. [4]
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.
Other criteria used to define a drug as specialty include "biologic drugs, the need to inject or infuse the drug, the requirement for special handling, or drug availability only via a limited distribution network". [3] The price of specialty drugs compared to non-specialty drugs is very high, "more than $1,000 per 30-day supply". [4] [5]
[citation needed] More recently, the term has been used to indicate a drug that reduces the rate of damage to bone and cartilage. [citation needed] DMARDs can be further subdivided into traditional small molecular mass drugs synthesised chemically and newer "biological" agents produced through genetic engineering.
The term "biological target" is frequently used in pharmaceutical research to describe the native protein in the body whose activity is modified by a drug resulting in a specific effect, which may be a desirable therapeutic effect or an unwanted adverse effect. In this context, the biological target is often referred to as a drug target.