This week, the US Court of Appeals for the Federal Circuit affirmed a district court decision against Pfizer subsidiary Hospira related to an epoetin alfa biosimilar.
This week, the US Court of Appeals for the Federal Circuit affirmed a district court decision against Pfizer subsidiary Hospira related to an epoetin alfa biosimilar.
This week’s development stems from the fact that, in 2017, a jury found that Hospira infringed on Amgen’s US Patent Number 5,856,298 (the ’298 patent), which covers erythropoietin, when Hospira produced batches of a biosimilar epoetin alfa that was eventually approved by the FDA and then launched in late 2018 under the name Retacrit.
The court at that time ordered the biosimilar developer to pay Amgen, the maker of the reference epoetin alfa (Epogen), $70 million.
Hospira had unsuccessfully argued during the trial that its batches of the drug were part of its FDA approval process, and that its development of a biosimilar product was protected under safe harbor.
Hospira then asked the court for a judgment that producing batches of a biosimilar product is an activity protected by safe harbor provisions, that Hospira did not infringe on the ’298 patent (which Hospira said was invalid, though the jury disagreed), and that damages owed to Amgen not exceed $1.5 million per batch of the drug if those batches were later sold. Alternatively, it sought a new trial in the case.
Hospira was denied those requests in 2018; a district court agreed with Amgen that not all of the batches of epoetin alfa that were produced by Hospira were reasonably related to seeking FDA approval, and so only some batches were subject to safe harbor. The memorandum also supported the jury’s $70 million lump-sum damages award.
The new opinion in the case, the court affirmed the prior ruling on all grounds, saying that the jury’s findings of that certain batches of the epoetin alfa biosimilar were not protected by safe harbor are supported by “substantial evidence,” and rejecting Hospira’s suggestion that “simply submitting information about a drug substance lot to the FDA brings the manufacture of that lot within the Safe Harbor.”
The court upheld the $70 million judgment with the addition of interest.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.