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New Biologic Drug Development Aiming for Record High

New Biologic Drug Development Aiming for Record High

Nearly 1,000 vaccines, treatments in testing or under review.

antibody biologicThe doomsayers who predicted the end of the pharmaceutical industry may be half right. The “patent cliff,” which removed exclusive protection from blockbuster chemical treatments from the portfolios of big pharmaceutical firms, triggered a rise in new drug development.

The only catch is (and here’s where the Cassandras were right); the new drugs are from biotech, not traditional chemical, small-molecule drugs. According to the U.S. Pharmaceutical Research andManufacturer’s Assocation (PhRMA), 907 vaccines and treatments, all biological, are currently either undergoing clinical trials or have been submitted for review by the U.S. Food and Drug Administration (which also means that submission to the European Medical Agency (EMA) has either happened or won’t be long in coming.

The potential new drugs are targeted at 100 diseases, including 338 treatments for cancer, 174 infectious disease drugs (of that, 134 are vaccines), 71 treatments for such autoimmune disorders as multiple sclerosis or lupus, 58 cardiovascular drugs, and 81 for a wide range of disorders.

aspirin chemicalTopping the list of types of biologics are monoclonal antibodies, followed by vaccines. Other methods include cell therapy, recombinant proteins, antisense (using biological methods to bypass immune cells), and even gene therapy, which has ridden a rocky road over the years.

Biological therapies and preventatives, much more complex than chemical therapies due to biologics’ sheer size and physiological complexity, are more difficult to develop (compare an influenza antibody, above left, to aspirin, right). But they also contain the promise of more targeted therapies, fewer side effects, and the development of personalized medicine. And now, to use an American baseball term, they’re almost batting 1000!

Source: PhRMA

Pictures: NCBI

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