Are Generic Biologics Impossible?

Democracy in Action is hosting a campaign for the inclusion of a workable path towards the approval of generic versions of biologics, into healthcare reform legislation. Apparently, biologics are more than 20 times as expensive as your normal run-of-the mill pharmaceutical drug. There seems to be a certain reluctance on the part of pharmaceutical producers to give up that price advantage.

According to Merck’s website, “biologic drugs are complex products that can be derived from viruses, blood and body tissues, antibodies, toxins and antitoxins, vaccines, and related products used for treating disease.”

They differ from traditional drugs, which are called “small-molecule agents because the active ingredient is usually a single, discrete chemical entity.”

Merck also states that “until now, it has not been possible to develop generic versions of these products because of their complex manufacturing requirements and the difficulty in defining their exact composition. Companies have made several attempts to get approval for generic equivalent biological products, such as human growth hormone. However, the Food and Drug Administration has required manufacturers of the proposed products to submit for approval under new drug regulations rather than as a generic equivalent.”

Democracy in Action confirms that there is currently no legislative pathway to manufacture and get approval for a biologic drug’s generic equivalent. Their proposed letter to Congress spells out the situation:

Unfortunately, the mechanism for generic or “follow-on” biologics built into Senate HELP Committee and House Energy and Commerce Committee versions of health care reform threaten to effectively block generic competition by granting 12 years of monopoly protection through data exclusivity (other medicines get only 5 years) in addition to the patent protection that biologic drugs already receive. In addition, companies can make relatively inexpensive tweaks to their drugs (for instance by changing from two injections a day to one) and extend this protection for another 12 years… over and over again. That’s an additional 12 years of high prices that they can turn into a perpetual monopoly. In other words, this purported generic biologics proposal will actually PREVENT biologic generics.

Big Pharma charges 22 times more for biologics than for other drugs, despite comparable R&D costs and biologic drugs already account for 43% of Medicare Part B drug spending. Done right, in the first decade, biogenerics could save patients and our healthcare system as much as $71 billion, making lifesaving medicines available to many patients who now have to do without.

But there is still time to fix this by making a true path for affordable generic biologics. Representative Henry Waxman and Senator Charles Schumer have proposed generic biologics legislation (H 1427/S 726) that grants the same amount of protection given to traditional drugs, 5 years, and prevents abusive practices that allow companies to extend that protection indefinitely.

For more information on this and to email or fax Congress:

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