Almost a third of newly approved drugs are cold chain products


Key oncolytics will require cold chain storage; room-temp products still have varying temperature requirements

The final list of FDA-approved new molecular entities for 2014 has several notable trends: at 41, it represents a new high in successful applications not seen since 1996. And while there are numerous products for rare diseases—a trend that has been developing for several years, and for products that will be used by only a limited number of patients—there are some expected blockbusters, and some of those require cold-chain (2-8°C) storage and handling. Among these are Merck’s Keytruda (pembrolizumab) and BMS’s Opdivo (nivolumab), both so-called PD-1 inhibitors that target a variety of cancers.

Pharmaceutical Commerce has gone through the prescribing information of each of the newly approved products. The result: 29%, or 10, of the 41 products require cold chain handling. This isn’t a surprise—most biologics require refrigeration, and biologics are the direction the biopharma industry is going in. Previously published data in Pharmaceutical Commerce’s annual Cold Chain Sourcebook indicates that today, between 5-10% of pharma products require refrigeration. But as time goes on, and as the proportion of biologics rises, that percentage will increase as well.

A mild complaint among life sciences supply-chain professionals is that “controlled room temperature” (CRT) products lack a standard, recommended temperature regime, which can complicate storage and documentation processes. That situation still holds; the non-cold-chain products have label recommendations of “under 30°C,” 20-25°C,” and one has “2-25°C,” which means it needs to be kept separate from CRT products with the "under 30°C" label.

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