Are Generic Biotech Drugs Coming Soon? Some congressional staffers are working on bill to allow generic versions of expensive biotech drugs. But critics say that testing the knockoff's safety and effectiveness is trickier than it sounds.
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Are Generic Biotech Drugs Coming Soon?

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Are Generic Biotech Drugs Coming Soon?

Are Generic Biotech Drugs Coming Soon?

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From NPR News, this is ALL THINGS CONSIDERED. I'm Andrea Seabrook.


And I'm Michele Norris.

While Congress is away this month, House and Senate staffers are working on a bill aimed at helping patients who rely on innovative biotech drugs. Those medicines can cost as much as several thousand dollars a month. Generic versions of the drugs would surely be cheaper.

Opponents of generic versions say making sure those knockoffs are safe and effective may be trickier than it sounds.

NPR's Joanne Silberner reports.

JOANNE SILBERNER: 51-year-old Donna Gosbee came from Wyoming to Washington to attend a meeting of the Multiple Sclerosis Society. She is using a walker.

NORRIS: I never know from one day to the next until I put my feet down on the floor whether I'm going to be able to walk.

SILBERNER: Gosbee was diagnosed with multiple sclerosis four years ago.

NORRIS: The doctors put me on one of the biologic drug, Betaseron. I've been on it for three years now. And this drug costs about fifteen hundred dollars a month.

SILBERNER: The government helps her with some of the cost, but she's worried the help won't always be there. So she's come to Washington to lobby Congress.

NORRIS: I'm going to talk to the Wyoming legislators and try to convince them that for people with chronic illnesses that medications are just - they're just out of reach of the normal person.

SILBERNER: A generic could significantly cut her medical bill. At, for example, the generic version of the statin drug Mevacor is only one-third the price. But Gosbee's drug is manufactured very differently by living bioengineered cells.

Roger Williams says they make molecules that are much bigger than most conventional drugs and a lot more complex. He's CEO of U.S. Pharmacopeia, a non-profit organization that sets standards for drug manufacturers.

SEABROOK: If I showed you on a page the molecular structure of a biologic it might cover two pages, just as carbons and nitrogens and hydrogens and oxygens.

SILBERNER: In contrast, he says the structure of many conventional drugs fill less than half a page. Williams says making conventional drugs is like snapping together Tinker Toys. You add one chemical after another, and the manufacturer is very much in control.

Making a biotech drug is more like farming. You start with a living cell, then keep the temperature, the nutrients and other growing conditions just right. Just as wheat grown from a different seed stock or under different conditions will produce slightly different grain, different versions of biotech drugs can vary - even when made by the same company.

Here in Gaithersburg, Maryland, a company called Medimmune makes the biotech drug Synagis. Synagis fights a virus called RSV that can kill premature babies. Just getting into this place takes work. You've got to put on booties, gloves and a double set of what looked like surgical scrubs and go through multiple airlocks.

NORRIS: We're going through yet another airlock. All of our operations...

SILBERNER: Sterility is important for conventional drugs, too, but it's especially important here. If bacteria or viruses get into the cell cultures, they could disrupt the manufacturing process and wind up in the final drug.

U: Here, we have another...

SILBERNER: Workers take large beakers of living cells in culture from a refrigerator. The cells go into gleaming metal vats the size of small cars. Medimmune vice president Tony Latrelle explains what's going on.

NORRIS: This is the start of our bioreactor train.

SILBERNER: There are enough pressure monitors and temperature gauges and pipes to do a science fiction movie proud. Conventional manufacturers use temperature gauges too, of course, and that's filled with buckets of chemicals. But these vats hold mouse cells, each one loaded up with human DNA. The human DNA is directing the cells to produce a particular protein - an antibody that can fight RSV.

If you want to make a copy of Medimmune's drug, you would have to insert some human DNA into mouse cells in a precise way - a way that will produce that protein. It's a real challenge.

NORRIS: How do you say that you can easily accomplish that when one little change, one little genetic change, one little change in the way the protein is configure or the way the protein holds onto each other may have an effect on how it actually acts in the clinic.

SILBERNER: Then you've got to be really careful about how you grow the cells, says Roger Williams of U.S. Pharmacopeia. For example, temperature can make a big difference. Look at albumen, the protein in egg whites.

SEABROOK: If you take egg white and cook it, that's okay to eat, but it's no good to the chicken anymore.

SILBERNER: Williams thinks some biotech drugs could be made generically. But the only way to know for sure that a different version would be just as safe and effective is to do something not required for conventional generic drugs: lengthy and expensive testing in animals or people.

T: The House and Senate have not yet passed the bills. There have been two hearings in subcommittees of the House of Representatives, and a Senate committee has approved legislation.]

And generic companies and patients waiting for less expensive drugs aren't happy either. Both bills would make generic companies wait 12 years before they could market a cheaper drug, not much different from conventional generics, but a long time when you're spending several thousand dollars a month to fill a prescription.

Joanne Silberner, NPR News, Washington.

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