Apobiologix wins patent case against Amgen

Biosimilars company Apobiologix has won a patent infringement litigation against Amgen centring on the drugs Grastofil (filgrastim) and Lapelga (pegfilgrastim).

In the ruling on September 6, the US District Court for the Southern District of Florida ruled that the manufacturing process of the two drugs belonging to Apobiologix did not infringe Amgen’s US patent number 8,952,138, expiring in July 2031.

Steve Lydeamore, president of Apobiologix, said in a statement: “The court decision against Amgen brings us one critical step closer to making these innovative biologics available in the US."

He added: “Our patent infringement victory underscores the urgent need for the Supreme Court to rule that biosimilar applicants can provide their notice of intent to market prior to securing Food and Drug Administration approval for their products, as intended by the Biologics Price Competition and Innovation Act (BPCIA).”

According to Apobiologix, the decision at the Florida court is the first in which a biosimilar applicant proceeding under the BPCIA has achieved a district court victory.