Imagine a new drug has hit the market. It’s supposed to “revolutionize” the care of diabetics all over America – it’s commercial said so remember!? Well, if you are the Director of Pharmacy at a large medical center, you probably wouldn’t take their word for it.
So, how do you decide whether it is worth adding to the hospital’s formulary or not? The year is 1928, it’s the height of the roaring 20’s, and people are suffering.
Pneumonia, rheumatic fever, and gonorrhea are leaving thousands in agony, and doctors can do little to help. Fortunately, there is hope. Alexander Fleming, a Professor working at St. Mary’s in London, makes one of the greatest discoveries for humankind: penicillin. No longer would these plagues sweep populations, there was now a way to fight back. Fleming personally began what we now refer to as ‘The Age of Antibiotics’, an era antibiotic discovery that has spared hundreds of millions Last year the U.S. Food and Drug Administration approved the first ever biosimilar drug for use in the U.S. and is expected to approve another this year. A biosimilar of a biologic drug is often likened to a generic version of a brand name chemical drug. The main differences are that biologics are much larger, more complex, and they cost a lot more money to develop and produce than small molecule chemical drugs (approximately $100-250 million vs. $2-3 million respectively). A biosimilar is an inexact replica of a biologic drug. Since biologics are produced by unique cell lines and are composed of thousands of atoms, exact replicas from other companies (like generics) are nearly impossible. So a biosimilar drug is one that has similar chemical, therapeutic, and side effect profiles as its reference biologic, but it is not exact, allotting it the potential to interact differently in patients. |
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