Apotex Biosimilars Do Not Infringe Amgen Patent, But Still Tied To Market Notice

A federal district court in southern Florida ruled that Apotex's biosimilars pegfilgrastim and filgrastim do not infringe on Amgen's manufacturing process patent, marking a win for the biosimilar maker. This comes as the Federal Trade Commission reasserts its view that innovator biologics do not need exclusivity periods because they already have the ability to rely on patents to ward off biosimilar competition. The court specifically found the Apotex's biosimilars will not infringe on asserted claims of Amgen’s ‘138 patent, which...