Swiss drug maker Roche has filed a lawsuit against Pfizer in a Wilmington, Delaware federal court, seeking to block the rival developer from launching a biosimilar trastuzumab in the United States.
Swiss drug maker Roche has filed a lawsuit against Pfizer in a Wilmington, Delaware federal court, seeking to block the rival developer from launching a biosimilar trastuzumab in the United States.
Bloomberg Technology reports that Roche subsidiary Genentech, maker of the blockbuster Herceptin, claims that a biosimilar would infringe on 40 of its patents. Genentech’s complaint asks the court to order compensation for lost sales if Pfizer launches a biosimilar prior to Herceptin’s US patent expiry.
While this legal action marks the first time Roche has sued over a biosimilar in a United States court, the lawsuit is not the first legal challenge related to Pfizer’s development of its proposed trastuzumab molecule. In July 2017, the US Patent Trial and Appeal Board (PTAB) instituted Pfizer’s petitions for inter partes reviews (IPRs) filed by Pfizer subsidiary Hospira against 3 patents covering Herceptin (though the PTAB denied an IPR petition for a fourth patent). Then, in October 2017, Pfizer filed another petition for an IPR of an additional Herceptin patent.
Legal action over trastuzumab is also not Pfizer’s first foray into legal battles over biosimilars; Pfizer launched the first biosimilar infliximab product (Inflectra) in the United States in October 2016, and has proactively litigated against Johnson & Johnson, sponsor of the reference infliximab (Remicade), claiming that Johnson & Johnson engaged in anti-competitive practices that were intended to block Inflectra from gaining formulary placement.
While Pfizer has not yet announced its submission of a Biologics License Application for its proposed trastuzumab biosimilar, it has released positive data from a comparative clinical trial comparing PF-05280014 to reference trastuzumab in patients with operable HER2-positive early breast cancer. The study demonstrated that PF-05280014 had similar safety, efficacy, and immunogenicity to its reference, and that it was non-inferior, in terms of pharmacokinetics, to the reference drug.
Pfizer’s pipeline also contains a number of other proposed biosimilars; the drug maker reports that it is in phase 3 development of biosimilars referencing adalimumab (Humira), bevacizumab (Avastin), epoetin alfa (Epogen, Procrit), and rituximab (Rituxan, MabThera). Forbes reports that the total sales of the reference products targeted by Pfizer totaled over $35 billion in 2014, and that “Theoretically speaking, replacing [these drugs’] entire sales with biosimilars even with a 50% pricing discount will open up a market worth nearly $18 billion for Pfizer.”
The Trump Administration’s Drug Price Actions and Why US Prices Are Already Sky-High
May 17th 2025While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more complex web of development costs, profit incentives, and absent price controls—raising the question of whether any single policy, including potential drug tariffs, can truly untangle it.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.
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?
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
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.