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FDA Unveils Biosimilars Guidance

ananyo writes "The U.S. Food and Drug Administration has released its long-anticipated draft guidance for drug makers interested in making generic forms of biological drugs such as enzymes and antibodies. The move could open the door for cheaper versions of some of medicine's most expensive drugs, but it is still unclear how many companies will be willing to tackle the challenges and uncertainties of making 'biosimilar' drugs. Copying biological molecules is a stickier proposition than making ordinary generic medicines because proteins are typically much larger and more complex than small molecule drugs. They are also often produced in cell cultures, and even small variations in how the cells are grown can change the properties of the protein produced."

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  1. Re:Despite the costs it'll still happen by Ethanol-fueled · · Score: -1, Offtopic

    After coming home from a hard-day's work on a Friday evening, I noticed something awful on Slashdot - Besides those already awful Facebook, Twitter, and G+ icons was a flag icon.

    "Mother of God," I thought, and many of you thought the same when you first saw it, instantly knowing what it meant.

    First, a little background - Slashdot(then known as Chips and Dips) was initiated by pseudonym Commander Taco in 1997. It was later augmented by pseudonym Hemos and the whole thing became Slashdot. By the way, what was to become one of the foremore discussion sites for science and technology was started by a religious twig and a fat fuck*

    * there's a joke there, we're gonna get to it... Yes, not that joke, but another joke, was that the some of the perceived online proponents of science news were actually Hopeless religious lunatics! And, like CommanderTaco and Hemos, I joined and spewed the filth internalized by priest rape without mentioning the dirty little secret. Not only were the two founders deeply religious, they had a preference for PERL(which, of course, is written and directed by an evangelical lunatic). Larry Wall had raped the two himself while on a religious mission to a Michigan dildo store, and they both gobbled his wholey language (among his other things) down and asked for seconds.

    There's a joke here, too - Slashdot considers itself a bastion of free speech. It prided itself for not deleting any comment, unless the circumstances were so dire that they threatened its own existence. They rightly publicised their first monumental loss, against the church of Scientology. Now it wants to "flag posts." For what? Reporting to homeland security? Flagging is not in the FAQ.

    Historically, even though the moderators acted as the Basij(to quote another Slashdot reader from years ago) that charasmatic trolls could not be silenced. Now, with the flag icon, Slashdot has gone full censor.

    If their awful flagging cannot be destroyed by asking or pleading, it must be destroyed by trolling. flag every high-scoring comment you can, and offer a technical explanation why that comment should be flagged. When your comments disappear because of some jackass who doesn't agree with you, attack the advertisers next. Contact their advertising or PR department and say, " I was trying to say online how great your products were, but Slashdot's censorship system prevented others from seeing my comment. " Flood their advertisers with those comments until those awful flag icons disappear entirely and Slashdot releases a statement regretting the use of flags.

    Oh, that joke you were wondering about. Hemos is now skinny and Commander Taco is now fat. And the Jew Timothy and his overlords at the JIDF are still in charge of Slashdot.

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