Pharmaceuticals Regulation

First biosimilar hits the market

Making a generic version of a single molecule drug is fairly straightforward.  Making a replica of a biologic treatment, however, is not.  Nevertheless, Congress signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) to create a fast-track approval process for biological products that are demonstrated to be highly similar an FDA-approved biological product.  These products are known as biosimilars.

Today, this legislation has bore fruit.   FierceBiotech reports:

The FDA accepted Novartis’ application to sell a knockoff of Amgen’s biological treatment Neupogen, making the company a pioneer among those looking to capitalize on a soon-to-come U.S. market for biosimilars that is expected to explode.

Novartis is the first to file for a U.S. biosimilar approval under the FDA’s newly created pathway, according to the company, looking to market its take on a treatment for patients with low white blood cell counts that brought in $1.4 billion for Amgen last year. The drug, developed as filgrastim, is designed to prevent fever and infections in cancer patients taking chemotherapies that hamper bone marrow activity.

Is this a breakthrough? Yes and no. Although biosimilars are new to the US, Sandoz (the generic division of Novartis) already sells three biosimilar drugs, including filgrastim, in about 60 other countries.

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