On Friday, Pfizer announced that it has signed an agreement with AbbVie that resolves all intellectual property disputes related to Pfizer’s PF-06410293, a proposed biosimilar adalimumab referencing Humira.
On Friday, Pfizer announced that it has signed an agreement with AbbVie that resolves all intellectual property disputes related to Pfizer’s PF-06410293, a proposed biosimilar adalimumab referencing Humira.
Under the terms of the settlement, Pfizer will be permitted to launch its biosimilar at the time of approval in the European Union and on November 20, 2023, in the United States.
“This settlement will facilitate patient access to Pfizer’s proposed adalimumab biosimilar which we expect to be an important addition to our broad portfolio of biosimilar medicines,” said Richard Blackburn, global president of inflammation and immunology at Pfizer, in a statement.
AbbVie’s announcement of the license agreement added that, while the full terms of the deal are confidential, Pfizer will pay AbbVie royalties on its sales and acknowledges the validity of patents covering the reference Humira.
PF-06410293 has not yet been approved by the FDA or European Medicines Agency, but Pfizer recently announced positive clinical data for the product. In August of this year, researchers published results demonstrating that the biosimilar shares similar efficacy, safety, and immunogenicity profiles with Humira at 26 weeks of treatment in patients with rheumatoid arthritis that has not adequately responded to methotrexate. Further results from the 78-week, double-blind, multicenter, randomized study—which involve rerandomization of patients in the reference arm at week 26 to either continue receiving the reference or switch to the proposed biosimilar, as well as a switch of all remaining patients in the reference-only arm to the biosimilar at week 52—are forthcoming.
The deal over PF-06410293 is the latest in a recent spate of settlements; Amgen, Mylan, Samsung Bioepis, Sandoz, Fresenius Kabi, and Momenta have also settled their patent litigation in exchange for launch dates in 2023. The only biosimilar developer not to settle is Boehringer Ingelheim (BI), sponsor of the already approved Cyltezo. Last week, BI told The Center for Biosimilars® that “Our focus is on bringing Cyltezo (adalimumab-abdm) to the US market and we are committed to making it available to US patients as soon as possible, and certainly before 2023.”
HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain
November 28th 2023Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
Biosimilar Business Roundup for October 2023—Podcast Edition
November 5th 2023On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.
Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar
November 22nd 2023Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).
Biosimilars Business Roundup For August 2023—Podcast Edition
September 5th 2023On this episode, we’re giving an overview of some of the biggest stories in the business space regarding biosimilars, like the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and some analyses about the health of the market.
AMCP Nexus: Panelists Share Current Scope of Biosimilar Industry
October 26th 2023Panelists at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting chronicled the current state of the US biosimilar market, including current policies impacting the market, recent regulatory decisions, and the developing arguments around requirements for clinical efficacy studies.
Report: Conflicting Guidelines, Rebate Walls Are Major Factors Determining Biosimilar Uptake
October 24th 2023Samsung Bioepis’ most recent biosimilar market report identified inconsistent medical guidelines, challenges with access and rebates, and acute vs chronic treatment duration as major factors influencing biosimilar uptake in the United States.