in this month's Scientific American (Dec.'03), on p.48 is a single page story titled: "Can Cells Be
Generic?" with a single pic showing a vial of name brand rDNA "human" insulin and a vial labeled
"Acme "human" insulin"
sorry about any typos (i copied it down longhand at a store 🙂, my own questions
(i.e. unreadable handwriting 🙂)) are enclosed in braces
the essence is this:
<" ... The FDA {and Europe} are pondering the question now, and a great deal of money hinges on
their decisions.
The patents on the first lucrative {right word?} products of biotechnology are at last nearing
their expiration date. {2 vials of "human" insulin shown in pic {name brand and "Acme"}} -- If
competing firms are permitted to manufacture them, "biogeneric" versions of the off patent
medicines could command $5 billion {!!} {$5 billion {!!} $5 billion {!!}} next year, estimates the
Strategic Research Institute, a consultancy in New York City. ...
Unlike drugs, which are synthesized using reproducible chemical procedures, biotech medicines --
or "biologics," as insiders call them -- are fabricated from bacteria, farm animals and other
organisms that have a life of their own. Biologics are typically large molecules, such as
hormones, antibodies or cytokines. Most are constructed from proteins, which are too complicated
to make from scratch. To function properly, a protein must be folded up a certain way and must
have sugars and other chemicals added to particular spots on the macromolecule. ...
Only a very large trial could have detected the problem with Orthi's {sp?} revised formulation,
because it affects only a small fraction of patients. The dilemma that regulators face is whether
to require generics firms to conduct such large, lengthy and expensive trials -- thus effectively
raising the price of biogenerics -- or whether to make informal guesses about whether subtle
differences in the generic version will harm patients. ...">
bill, t1 since '57