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Preparing for Biosimilars

Preparing for Biosimilars

Manufacturers of biologic drugs over the past few years have been “pulling out all the stops” to make it difficult for less expensive biosimilar products to come to market.  Biologic drug manufactures have used tactics like patent infringement suits to delay the availability of biosimilars.

Note: Biosimilars are the “generic” equivalent of a biologic drug.  Unlike traditional drugs, biologics are made from living cells and cannot be copied exactly to make generic versions. They are used to treat a range of conditions, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, plaque psoriasis, breast cancer and diabetes. 

The U.S. Supreme Court, in a recent 9-0 ruling, reduced one of the barriers for biosimilars by overturning a lower court’s decision that had prevented biosilimar drugs from coming to market quickly.

For example, Novartis, the Swiss pharmaceutical company, has been prevented from marketing a biosimilar of California-based Amgen’s Neupogen until six months after the U.S. Food and Drug Administration (FDA) approved it.

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BACKGROUND

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