FDA Unveils Biosimilars Guidance

For pharmaceuticals, small-molecule drugs and biologicals have long been regulated under two different tracks, for reasons both historical and practical (including the problem that biologicals simply aren't amendable to the kind of complete analysis you can do on small molecules). Sometime ago (maybe about a decade or so?) back, the FDA decided to modernize things, and start applying principles from the former track to the latter. There were a lot of facilities that used processes little-changed since being invented back as far as the 50's and 60's, that were shuttered; recent product and vaccine shortages happened not long after the number of manufacturers dwindled (for some products, from double-digits down to 1-2 sources).

Anyway, wanted to give an example of the limitations of characterizing biologicals. A while back, there was a case involving an Erythopoetin drug (used to treat certain kinds of anemia). The FDA mandated a change in manufacturing, in a big push to get rid of animal-derived raw materials (in this case, anything bovine-derived, following the mad-cow scare). The protein drug in the new formulation was found to be exactly the same by every testable parameter -- sequence, folding, everything else -- and seemed to function the same when examined in animal and human subjects. But when it was released for use in the field, there was a sudden spike in cases of pure red blood cell aplasia (where the body simply stops make any RBCs). Little details in the manufacturing process can sometimes make an enormous difference.

To use an analogy, biologicals are sometimes like arcane and kludgy code that nobody fully understands; once you somehow get it working, there is good reason to not to poke it, and to fear that it might break in somebody else's hands.

Source: http://rss.slashdot.org/~r/Slashdot/slashdotScience/~3/Rmof0nNG1l8/fda-unveils-biosimilars-guidance

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