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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 ...
In determining bioequivalence between two products such as a commercially available Branded product and a potential to-be-marketed Generic product, pharmacokinetic studies are conducted whereby each of the preparations are administered in a cross-over study (sometimes parallel study, when a cross-over study is not feasible) to volunteer subjects, generally healthy individuals but occasionally ...
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 U.S. Food and Drug Administration is holding a two-day public hearing to start the process of creating an abbreviated approval procedure for so-called biosimilar and interchangeable biological ...
(Reuters) -The U.S. Food and Drug Administration (FDA) on Monday approved two close copies of Regeneron Pharmaceuticals' Eylea, its first-ever clearance to biosimilar versions of the blockbuster ...
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.
Antiretroviral drugs are used to manage HIV/AIDS. Multiple antiretroviral drugs are often combined into a single pill in order to reduce pill burden. Some of these combinations are complete single-tablet regimens; the others must be combined with additional pills to make a treatment regimen.
csDMARDs are the traditional drugs (such as methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, gold salts) tsDMARDs are drugs that were developed to target a particular molecular structure; biological (bDMARD) can be further separated into original and biosimilar DMARDs (boDMARDs and bsDMARDs)