On June 2, 2025, Sandoz announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are now available to patients in the United States. ...more
On March 5, 2024, the FDA approved Sandoz’s Jubbonti® and Wyost® (denosumab-bddz) as the first biosimilars of Amgen’s Prolia® and Xgeva® (denosumab). The launch date for these biosimilars has not been announced as Amgen and...more
On September 9, 2022, Biogen filed a complaint in the District of Delaware against Sandoz and Polpharma Biologics. Biogen’s complaint is filed under seal. Based on the list of 28 asserted patents, the case appears to...more
In July, a divided Federal Circuit issued a ruling in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499 appeal and held: (1) the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent dance” provisions...more
On September 3, 2015, Sandoz Inc. (“Sandoz”) announced that it launched the first biosimilar in the United States, Zarxio® (filgrastim-sndz). Sandoz began marketing Zarxio® following a Federal Circuit Order to permit it to...more
As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for...more
On July 21, 2015, the Federal Circuit issued a key decision regarding the meaning of various provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Sandoz Inc., Fed. Cir. Case No....more
In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that...more
In a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz's...more
On March 6, 2015, the U.S. FDA announced that it had approved Zarxio, making Sandoz the first company ever to obtain approval of a biosimilar product in the U.S. The FDA deemed Zarxio to be biosimilar to Amgen’s Neupogen...more
As noted in our previous client alert, FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act, Sandoz Inc. (“Sandoz”) filed the first biosimilar application under the Biologics...more
The United States District Court for the Northern District of California ruled November 12, 2013, that a party seeking to obtain approval of a biosimilar could not avoid the process set forth in the Biologics Price...more