Generic Drug Zarxio Approved by FDA

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Generic Drug
The generic drug is named Zarxio. It has been approved by the U.S. Food and Drug Administration (FDA) as a generic drug to replace a very expensive version of a similar drug named Neupogen from Amgen. This drug has been produced and sold in a monopoly for years because there has been no other alternative. Now, the wait and monopoly is over.

Zarxio is a generic drug to help prevent infections in cancer patients undergoing chemotherapy. This drug is called a ‘biosimilar’ because it is biologically similar to the biologic Neupogen. Zarxio is considered a generic drug because it is not the same as Neupogen. By definition, biologics are made from living cells. This is why since the 80’s, biologics have been thought impossible to replicate generic versions of such drugs.

Thanks to the Healthcare Reform Law in 2010, companies are allowed to brand generic drugs as its own drug. Instead of a generic drug having the same brand name or no approval, generic drug companies can now wait for the brand name manufacturers to approve the drug within 60 days or go ahead with a generic version after 60 days.

Julie Masow, a spokeswoman for Novartis, which is Zarxio’s manufacturer, said the company has agreed to postpone selling the drug until the lawsuit comes to a conclusion or until April 10–the date in which they will start selling the generic drug version regardless. Zarxio drug treatment for 14 days is roughly $2,000 while a 14 day treatment with Neupogen is almost $2,700.

Amgen will lose millions if they do nothing against the knock off or generic drug. Amgen will do something though, they will make knock offs of the knock off. Nine biosimilars will be produced by 2017 to act as biosimilars to their own biologic. Amgen’s executive vice president for global commercial operations, Tony Hooper, admits that they will lose money to the biosimilars, but by getting into the biosimilar market they will gain more than they lose.

In the 1980s, the idea was that biologics could not be made generic. Consequently, a law was passed in 1984 that paved the way for other generic drugs to flood the market. However, biologics were not made generic because it was thought impossible. Years later, it was found that the biologics can be made generic, and they were called ‘biosimilars.’

An advisory board for the FDA unamiously voted for approval of Zarxio, and subsequently, the FDA followed their own advice and approved the biosimilars. This will help Medicare beneficiaries, who are paying co-pays for these drugs, because they will not have to pay as much since Zarxio, a generic drug, is less expensive than Neupogen. However, the two drugs are not interchangeable and patients who are taking Neupogen are required to be informed. Moreover, a doctor must agree if there are prescription changes to the generic drug, Zarxio.

Amgen took Novartis to court in an effort to block the sale of Zarxio. Amgen claims they were not given prior notice to the plans of sale for the generic drug. Novartis will not start selling until a decision is made or the April 10 deadline is reached.

Usually, pharmacies market the generic drug as the brand-name drug, but they cannot do that yet because biologic and biosimilars have not yet been deemed the same. Novartis and other biosimilar companies will either have to rely on the doctors to prescribe the generic drug or they will have to convince insurance companies to only allow the use of Zarxio, as it has already been approved by the FDA.

By Jacob Dowd

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Morgan Lewis
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