Court rules in favor of Apobiologix in biosimilars dispute with Amgen

Announcing an “unprecedented” positive court decision in its patent Infringement litigation against Amgen concerning its Grastofil (filgrastim) – a biosimilar of Amgen’s Neupogen - and Lapelga (pegfilgrastim) – Amgen’s Neulasta - products, Apobiologix also indicates that the company has filed a Petition for Certiorari with the US Supreme Court.

The new petition challenges the Federal Circuit Court of Appeal's ruling that the company may not launch its products until after providing 180-days' notice following regulatory approval by the FDA.

"The court decision against Amgen brings us one critical step closer to making these innovative biologics available in the US," said Steve Lydeamore, president of Apobiologix, a part of the Canadian generics drugmaker Apotex.