December 13, 2012

Russian Roulette in the Insulin Analogue Game

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The Diabetes Technology & Therapeutics article asks the question is the emergence of biosimilar insulin a cause for concern?

To know a little about the history of two royal subjects about to be dethroned, NovoLog and Levemir, we need to understand that the manufacturing process for analogues is still “patent pending”. With this in mind, the researchers ask if a global standard for quality assurance is going to be established for the safety and efficacy of the imminent “me too drugs.

What is the outlook for the future of these drugs? So far, the other designer analogues that have fallen off-patent have been replicated and sold in other countries that have less stringent regulations.  These generic drugs are not identical copes of their name brand model, but they are made the same way. This doesn’t guarantee the clinical safety or efficacy of the drug.

In the wake of this shady, researchers conclude that a worldwide standard of a biosimilar manufacturing process must be established for recombinant insulin and insulin analogues.  This is not crying wolf. This is seasoned architects of medical research stating the facts. Asking the FDA to protect public health by assuring the safety and efficacy of drugs in not above their pay grade.  It’s their job.

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