by April Breyer Menon | May 8, 2024
According to a May 1, 2024 press release, the high-concentration (100 mg/mL), citrate-free formulation of Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm) was approved by the FDA on May 1 as interchangeable with AbbVie’s Humira® (adalimumab) to treat multiple chronic...
by April Breyer Menon | May 3, 2024
On April 16, 2024, the PTAB proposed new rules (“proposed rules”) governing the Director Review process, which would remain consistent with the Interim review process currently in place, and codify those procedures. The types of cases available for Director Review...
by April Breyer Menon | May 3, 2024
First Actemra® Biosimilar Launch – Fresenius Kabi’s Tyenne® (tocilizumab-aazg) On April 15, 2024, Fresenius Kabi announced the U.S. launch of Tyenne® (tocilizumab-aazg), the first Actemra® (tocilizumab) biosimilar to launch in the U.S., after receiving FDA approval in...
by April Breyer Menon | Apr 30, 2024
Amgen and Sandoz reached a settlement in Case No. 1:23-cv-02406 (D.N.J.) on April 29 just hours before a New Jersey District Court Judge (Christine O’Hearn) was scheduled to announce her ruling on Amgen’s preliminary injunction against Sandoz’s Jubbonti® / Wyost®...
by April Breyer Menon | Apr 25, 2024
On April 22, 2024, the PTAB issued Final Written Decisions in two related inter partes reviews, IPR2023-00070 and IPR2023-00074, upholding two patents that cover Zynteglo® (betibeglogene autotemcel), a gene therapy treatment for adult and pediatric beta-thalassemia....