Compliance Management / Large Molecule

Supreme Court Eliminates Wait Period for Biosims

Jun 12, 2017

RAPS

The U.S. Supreme Court ruled that biosimilar companies will not have to wait an extra six months after FDA approval before launching their new biosimilars, so their products would be available more quickly, according to an article in RAPS.

The case of biologics manufacturer Amgen versus biosimilar manufacturer Novartis/Sandoz aimed to clarify the biosimilars "patent dance," which is when companies must figure out the patent situation of a biologic and proposed biosimilar before the biosimilar comes to market, the story said. Sandoz argued that the waiting period basically created six months of additional exclusivity.

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