6 July 2016 - In a blow to biosimilar developers and consumers, the federal appeals court has again ruled that biosimilar makers must wait until they have an FDA approval in hand before giving the drugmakers a 6-month heads up that they intend to launch a knockoff.

The court was adamant in a ruling filed Tuesday that the biosimilar law “provides for two stages of litigation” and that drugmakers should get a second shot to make a last stand on patent issues after an FDA approval of a biosimilar. The ruling, while settling the question for now, will give the Supreme Court more to think about should it take up the issue, which it's been asked to do.

The U.S. Court of Appeals Tuesday again ruled in favor of Amgen in a fight over a biosimilar of one of its products, this time with Apotex, which has developed a copy of Neulasta. It said that even when a biosimilar developer has gone through all of the so-called patent dance preliminaries laid out in the federal biosimilars law, exchanging info on the biosimilar and patents on the reference drug, it can’t give notice until it has an FDA approval in hand. Apotex had served notice after first working through some of the patent issues with Amgen and then declaring the final patent was invalid, but before the FDA had approved its copy.

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