Court Denies Genentech’s Attempt to Block Amgen’s Herceptin Biosimilar

In a blow to Genentech’s blockbuster cancer drug Herceptin, a federal appeals court refused to temporarily suspend sales of Amgen’s biosimilar while a lower court considers a patent infringement challenge.

The FDA approved Kanjinti (trastuzumab-anns) as the first biosimilar for Herceptin (trastuzumab) and Amgen launched the product a month later.

Immediately after the launch, Genentech asked the U.S. District Court for the District of Delaware for a temporary injunction against the biosimilar while the court considered the company’s patent infringement suit. But the court denied the request and the Federal Circuit Court of Appeals upheld the lower court’s ruling. 

The decision leaves the biosimilar on the market while the lower court considers the patent infringement case.