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Drug Trade name Type Main indications Company Sales (USD millions/year) ∆ vs 2014 1 Adalimumab: Humira Biologic Rheumatoid arthritis: AbbVie Inc. 14,012 1,469 2 Ledipasvir/sofosbuvir: Harvoni Small molecule Hepatitis C: Gilead Sciences: 13,864 11,737 3 Etanercept: Enbrel Biologic Rheumatoid arthritis: Amgen. Pfizer. 8,697 4,009 4 Infliximab ...
Bioanalysis is a sub-discipline of analytical chemistry covering the quantitative measurement of xenobiotics (drugs and their metabolites, and biological molecules in unnatural locations or concentrations) and biotics (macromolecules, proteins, DNA, large molecule drugs, metabolites) in biological systems.
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 ...
In addition, it says that price negotiations for small molecule drugs (such as pills) can begin nine years after they reach market and large molecule drugs (such as injectables) can begin after 13 ...
It also differentiates between small molecule drugs, like pills, which will be granted nine years of exclusivity before negotiations begin, and large molecule drugs, or complex biologics, which ...
In addition to the oral medications, injectable drugs like Novo Nordisk's diabetes treatment Ozempic are considered small molecule drugs and subject to the shorter market time for negotiated prices.
One advantage that small molecule drugs (SMDs) have over "large molecule" biologics is that many small molecules can be taken orally whereas biologics generally require injection or another parenteral administration. [6] Small molecule drugs are also typically simpler to manufacture and cheaper for the purchaser.
There are many challenges for the successful translation of mRNA into drugs because mRNA is a very large and heavy molecule(10^5 ~ 10^6 Da). Moreover, mRNA is unstable and easily degraded by nucleases, and it also activates the immune systems. [54]