Yesterday, the Senate overwhelmingly (98-2) passed the “Patient Right to Know Drug Prices Act” (S.2554), which includes amendments to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) that require patent litigation settlements between a Reference Product Sponsor and a biosimilar applicant under section 351(k) to be submitted…
In a complaint filed yesterday, the State of California sued AbbVie, Inc. based on an alleged kickback scheme in connection with AbbVie’s Humira® (adalimumab). The complaint alleges that AbbVie violated the Insurance Frauds Prevention Act (“IFPA”) by providing kickbacks to health providers throughout California. Specifically, AbbVie allegedly indirectly paid healthcare…
On September 12, 2018, Boehringer Ingelheim announced positive results from a Phase III clinical trial for its approved adalimumab biosimilar, Cyltezo®. The clinical trial compared the efficacy, safety and immunogenicity of Cyltezo® and Humira® in patients with moderate-to-severe chronic plaque psoriasis. According to Boehringer Ingelheim, the study confirmed equivalence of Cyltezo®…
As we have previously reported, a jury in September 2017 issued a $70,000,000 verdict against Hospira based on its drug substance manufacturing activity in 2013-2015 in connection with its biosimilar of Amgen’s Epogen® (epoetin alfa). The parties then engaged in post-trial motion practice, seeking to overturn various portions of the…
Genentech recently submitted two opening appellate briefs to the Federal Circuit in connection with its appeals from the Board’s final written decisions in Hospira’s IPRs, IPR2016-01771 and IPR2016-01837, which found that the challenged claims of U.S. Patent Nos. 7,622,115 and 7,807,799, respectively, were unpatentable in view of the prior art….
As we reported here, on June 9, 2017, Mylan filed two IPR petitions challenging Sanofi-Aventis’s U.S. Patent No. 7,476,652 (IPR2017-01528) and U.S. Patent No. 7,713,930 (IPR2017-01526), related to Sanofi’s Lantus® (insulin glargine injection). Both petitions were instituted on December 13, 2017, as reported here. On September 10, 2018, Mylan filed ten additional…
As we have previously reported, the Immunex v. Sandoz patent litigation under the BPCIA concerning Sandoz’s Erelzi™ (etanercept-szzs) biosimilar is scheduled to begin trial today before New Jersey District Judge Claire C. Cecchi. Yesterday, prior to the start of trial, the Court entered a stipulation wherein Sandoz stipulated to infringement of…
Today, September 10, 2018, Xbrane Biopharma announced that it has decided to shift its strategic focus of capital and resources toward biosimilars and away from its pipeline of generic long-acting injectables. In addition to moving forward with its pivotal clinical trial for Xlucane, its proposed biosimilar of Lucentis® (ranibizumab), Xbrane…
Below we provide updates in three pending litigations. First, in an update on the Amgen v. Coherus appeal regarding Coherus’s biosimilar application for pegfilgrastim, Amgen filed its opening brief on August 20. Amgen’s statement of the issues reads: 1. Whether the district court erred in dismissing Amgen’s Complaint, with prejudice, based…
Yesterday, September 4, 2018, Genentech filed a complaint against Samsung Bioepis in the District of Delaware alleging infringement under the BPCIA of 21 patents based on Bioepis’s filing of an aBLA for SB3, a biosimilar candidate referencing Herceptin® (trastuzumab). This is the fourth litigation regarding a biosimilar of Herceptin®, following…