Will Purple Become The New Orange? FDA Publishes Long-Awaited Lists Governing Biologics
Sep 16th, 2014 by Michael Dilworth | News | Recent News & Articles |
Some fashion trends may come and go, but in the not too distant future the majority of prescription drug sales will be purple.1 For those of you not yet familiar with this latest trend, allow me to explain.
Most drug products are small, synthetically produced substances. The common pain reliever ibuprofen, for example, contains only 33 atoms and has a molecular weight of 206. In contrast, there is a whole new class of complex drug products that are isolated or produced from biological sources such as living cells. These biologically produced drugs, more commonly called “biologics”, are orders of magnitude larger than their small molecule cousins and present special challenges in their preparation, isolation, and administration. Insulin is a common example of a biologic. It is a protein having a molecular weight of approximately 5800. Another example is the hormone erythropoietin (or “EPO”), which is used to treat anemia. EPO is a far larger biological drug with a molecular weight of nearly 35,000.