The US Court of Appeals for the Federal Circuit today dismissed Amgen’s appeal of a previous district court ruling that denied its motion to compel discovery from Hospira in a Biologics Price Competition and Innovation Act (BPCIA) litigation.
The US Court of Appeals for the Federal Circuit today dismissed Amgen’s appeal of a previous district court ruling that denied its motion to compel discovery from Hospira in a Biologics Price Competition and Innovation Act (BPCIA) litigation.
In appealing the decision, Amgen had argued that, unless it was provided discovery of Hospira’s manufacturing process for epoetin alfa (Epogen), its right to sue over the cell-culture patents it holds for the drug would be thwarted. It alternatively sought a writ of mandamus, which would compel discovery.
The court, however, said that it lacked jurisdiction over the district court’s order, and found that Amgen failed to satisfy the prerequisites necessary for such a writ, calling it “a drastic remedy reserved for the most ‘extraordinary causes,’” in which the party has no other means of relief, and has demonstrated that it has a legal right to the writ by “clear and indisputable” means.
The court took the position that, barring an injunction under federal law (which the Supreme Court’s ruling in Sandoz v Amgen rendered unavailable), Amgen could have sought relief under state law (though it did not), sued for patent infringement, or coerced information from Hospira by bringing suit on its cell-culture patents. Moreover, the decision indicated, the Supreme Court appears to have provided for the possibility of the sponsor’s filing suit upon an applicant’s failure to disclose information.
The court stated that “the denial of discovery in this case does not undermine the purpose of the BPCIA," and that the district court was correct in its decision to deny Amgen’s motion.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.