High Court to Hear Key Case on Law Governing Biosimilars

The U.S. Supreme Court on April 26 will enter the fray over the so-called biosimilar "patent dance" and whether manufacturers of biosimilars have to notify reference product sponsors of the impending marketing of a new product. The high court’s eventual decision in the case is expected to have ramifications for all subsequent biosimilars approved by the Food and Drug Administration (FDA). Additionally, it could have an impact on the pricing of biosimilars, affecting the pocketbooks of millions of American consumers -- especially seniors. The case is expected to be decided by July. The decision could set a precedent not only on whether the patent dance is necessary (i.e., that companies must exchange patent and manufacturing information before FDA approval), but also whether manufacturers of biosimilars should be required to adhere to the so-called "notice of commercial marketing" provision. Such a requirement would likely add an additional six-month delay following FDA approval before newly developed biosimilars are allowed to be sold. The case at issue is Amgen v. Sandoz, and it has its roots in a dispute over the interpretation of the Biologics Price Competition and Innovation Act. The BPCIA spells out how biosimilars can garner approval and enter the marketplace. The law [...]

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4/21/17 5:42 PM

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