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Generic Versions of 'Biologic Agents' Unlikely in Near Future

WebMD Health News

Jan. 24, 2001 -- Bettina Irvine of Greenwich, Conn., spends $60,000 a year on a drug called Prolastin for a rare disorder known as genetic emphysema, which causes scarring of her lungs.

That's a lot of money, but the life-saving medicine is unlikely to get any cheaper -- or any more readily available -- because Bayer Pharmaceuticals Inc. is currently the only company to make it. "There have been shortages in the past, and we are expecting shortages in the future," Irvine tells WebMD. "We think there will always be shortages until another manufacturer comes along."

At least two other manufacturers are interested in developing a similar product, she says, but must first go through laborious and costly safety tests. Because Prolastin is a "biologic" agent -- that is, it's made from the human body rather than from chemicals -- there is currently no process in place by which drug companies might make cheaper generic versions.

Irvine's disease is rare, but her predicament is not, Abbey Meyers, president of the National Organization of Rare Disorders, tell WebMD. Many patients are spending even more than she on biologic drugs they can't live without, and the problem of sky-high prices is not confined just to unusual diseases, she says. For instance, cancer patients can spend extraordinary amounts of money on interleukin, a biologic agent derived from the immune system.

The mapping of the human genome will undoubtedly drive the development of new drugs for cancer, including biologics, says Gary Hudes, MD, director of the genito-urinary malignancies division at Fox Chase Cancer Center in Philadelphia. And as patents expire on biologic agents, questions will arise about possible new generic forms of them.

An example of how this might work, he says, is Herceptin -- known generically as trastuzumab -- a relatively new biologic drug born of the human genome project. Marketed by Genentech Inc. of San Francisco, Herceptin is used to treat breast cancer.

"There are going to be more and more drugs like Herceptin," Hudes says. "It is hard to believe that someone won't come up with generic forms of biologic agents when these patents end."

Yet development of generic versions of biologics is opposed by biotechnology firms, which say the complexity of biologic agents makes it virtually impossible to determine that a generic equivalent is really equivalent.

That view is backed by the federal FDA, which has expressed reluctance about developing a process for generic equivalents of biologic agents.

"There are significant unresolved scientific issues about how to show sameness between complex biological macro-molecules so that FDA can be assured that any generic biologic is safe, pure, and potent as well as equivalent to an innovator product," states Margaret M. Dotzel, the FDA's associate commissioner for policy. "These scientific issues are different and more difficult for biologics than they are for most ... generic drugs, most of which are made up of smaller and simpler chemically synthesized molecules."

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