As we previously reported in the Amgen v. Hospira district court litigation regarding Hospira’s proposed biosimilar of Epogen®/Procrit® (epoetin alfa), Amgen filed a motion for preliminary injunction seeking to enjoin Hospira from launching its biosimilar “until Hospira has complied with the requirement of 42 U.S.C. § 262(l)(8)(A)” (the notice of…
Sandoz announced today that it has received approval for the use of Rixathon® in Europe. Rixathon® is a biosimilar version of Roche’s MabThera® (rituximab) and is approved for use in all the same indications, including non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma), chronic lymphocytic leukemia, and immunological diseases…
On Wednesday, June 28, 2017, at 12:00 PM EST, Goodwin will host a webinar discussing the Supreme Court’s Decision in Sandoz v. Amgen. On June 12, the Supreme Court decided Sandoz v. Amgen, which presented the Justices with multiple significant questions about the correct interpretation and application of the biosimilars…
We previously reported on the oral argument in Sandoz v. Amgen. Today Justice Thomas delivered the opinion for a unanimous U.S. Supreme Court in Sandoz v. Amgen. Briefly, the Supreme Court held that notice of commercial marketing may be given prior to FDA approval, siding with Sandoz and reversing the Federal…
Two companies have announced that the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorisation Applications (MAA) for proposed biosimilar candidates. Fujifilm Kyowa Kirin Biologics Co., Ltd. announced that on May 18, 2017, the EMA accepted its application for FKB327, an adalimumab biosimilar candidate to AbbVie’s HUMIRA…
Below is our spring update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016, Midwinter 2017).
Cinfa Biotech, a Spanish company focusing on the development of biosimilars, announced positive results from their second clinical trial evaluating a biosimilar version of Amgen’s Neulasta (pegfilgrastim). According to the company’s press release, the trial demonstrates that Cinfa Biotech’s biosimilar is comparable to Amgen’s Neulasta in terms of pharmacodynamics, immunogenicity, and…
A Stipulation and Scheduling Order for Trial (Order) entered on May 19, 2017 in the Amgen v. Sandoz litigation rescheduled trial for March 26, 2018 (from December 18, 2017), and pushed back other pre-trial deadlines. According to the Order, the parties had previously proposed separate modified schedules, but at a…
To view our full FDA Approvals tracking table, click here. Last updated: July 16, 2025
Last week, Apotex filed a Citizen Petition requesting that FDA “take certain actions to ensure a robust approval process” for proposed biosimilars to Amgen’s Neulasta (pegfilgrastim). Among its requests, Apotex asks that FDA require each biosimilar applicant to conduct comparative clinical efficacy studies, including pharmacokinetics, pharmacodynamics, and immunogenicity studies, in at least…