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FDA OKs shortcut path for biosimilars


Washington — The Food and Drug Administration has created the first shortcut to the U.S. market for “biosimilar” medicines — cheaper versions of expensive and complex biologic drugs such as infliximab for rheumatoid arthritis, etanercept for plaque psoriasis and psoriatic arthritis, and erythropoietin for anemia.

The new FDA guidelines for the more inexpensive drugs are designed to help slow rising medical costs, the Wall Street Journal reports. Some experts predict that competition from biosimilars could save patients and the U.S. healthcare system billions annually.

The European Union already has more than a dozen biosimilar drugs on the market.

Because biologics are generally far more complex than other drugs, producing a true generic version — as opposed to a similar one — of the brand drug is impossible with today’s technology. Many of the knockoffs will be classified as comparable to branded biologics, but pharmacists will not be able to automatically substitute them. As a result, experts say, manufacturers will have to market biosimilars to doctors, as they do with brand-name drugs, as opposed to promoting them based on price as they do with generics.

Biosimilars are expected to cost 10 to 20 percent less than brand products. Traditional generics can be as much as 90 percent cheaper.

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