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Biosimilars –The Newest Addition to the Pharmaceutical Industry

Biosimilars –The Newest Addition to the Pharmaceutical Industry

Sep 15, 2015

Biologics are among the fastest growing sector of the pharmaceutical industry. Most drugs are small molecules, and are synthesized chemically. Biologics are different in that not only are they larger molecules such as proteins, but they require a finely tuned process to be produced from  a biological source, such as a cell line.

One popular category of biologics is monoclonal antibodies. They are like the antibodies produced by your immune system, but are made to target a specific pathway. For example, the top selling biologic adalimumab is used to treat rheumatoid arthritis and several other inflammatory conditions. It works by specifically targeting a protein called tumor necrosis factor-alpha so that it cannot initiate the inflammatory response it normally does. This results in a reduction of symptoms.

antibody

Because biologics require such specialized and precise protocols to produce, they are generally very expensive. Fortunately, many biologics are coming off patent within the next few years, and a new field of pharmaceuticals has emerged—biosimilars. Biosimilars are defined by the FDA as being highly similar to the reference product, rather than being an exact copy such as with small molecule drugs. The molecules must have similar dosages, strengths, routes of use such as injection. They also undergo rigorous testing to ensure purity and effectiveness.

Why do we care about biosimilars? Because they are poised to be much cheaper than the reference products they are similar to and this offers more options to patients and doctors fighting serious illnesses. As of now there is only one biosimilar approved for use in the US, Zarxio, which is now a competitor to Neupogen. The drug is used to increase white blood cell counts in cancer patients.  It will be interesting to see how the landscape of the pharmaceutical industry changes as companies compete with biosimilar products. The market is expected to take off with estimates for 2020 ranging from 6-11 billion dollars, with competition among companies resulting in lower prices for consumers. Only time will tell.

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Casey Raasumaa Rollins – Proofreader at Amgen and Columnist at QGITS. A Masters in Life Science from the University of Edinburgh. Linkedin

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