At yesterday’s earnings call for Q3 2016, Amgen indicated that, due to its ongoing litigation with AbbVie, Amgen is unlikely to launch Amjevita® (adalimumab-atto), its FDA-approved biosimilar of Humira®, before 2018. Amgen Chairman and CEO Bob Bradway stated: In biosimilars, AMJEVITA, which is of course our biosimilar to adalimumab, is…
As we previously reported, in July the FDA issued a complete response rejecting Sandoz’s aBLA for a biosimilar of Neulasta® (pegfilgrastim). Novartis, Sandoz’s parent, indicated that that Sandoz was “working with the agency to address remaining questions.” Earlier this week, on an earnings call for Q3 2016 with investors and…
Yesterday, Catalent Pharma Solutions announced that it has broken ground for a 22,000 square foot extension of its biologics manufacturing facility in Madison, Wisconsin. According to the press release, following completion of the expansion, Catalent will be able to provide biologics for late-stage clinical and commercial purposes. In addition, last…
Mylan filed an amicus brief in support of Apotex’s petition for certiorari in Amgen v. Apotex. Mylan’s arguments focus on the Federal Circuit’s interpretation of the BCPIA as requiring 180 days of pre-marketing notice after licensure of a biosimilar product by the FDA. It argues that the Federal Circuit’s decisions…
On October 19, Fujifilm Kyowa Kirin Biologics (a joint venture between Fujifilm and Kyowa Hakko Kirin), announced successful results in the global Phase 3 study of its Humira® (adalimumab) biosimilar candidate, FKB327. According to the press release, the study showed that FKB327 and Humira® performed equivalently at improving the disease activity of…
Earlier this week, we reported on the amicus curiae brief filed by the Biosimilars Council in support of Apotex’s petition in Amgen v. Apotex. Mylan Pharmaceuticals Inc. has also filed an amicus brief in support of Apotex. Mylan’s brief can be found here.
A study conducted by the Norwegian government compared Johnson & Johnson’s Remicade (infliximab) to Celltrion’s approved biosimilar Remsima. The “NOR-SWITCH” study, which cost $2.5 million, was a 52-week Phase IV study that began in October 2014. The results were presented on Tuesday during the United European Gastroenterology Week in Vienna, Austria. The…
On October 17, the PTAB denied institution of IPR2016-000912, IPR2016-00915, IPR2016-00916. The Petitions in these cases were filed by Swiss Pharma International AG on U.S. Patent Nos. 8,815,236; 8,349,321; and 8,900,577, respectively, all owned by Biogen. The patents all relate to compositions of natalizumab, marketed by Biogen under the brand-name…
As we covered in a previous post, Apotex has filed a cert. petition asking the Supreme Court to review the Federal Circuit’s ruling on the BPCIA’s notice provision in Amgen v. Apotex. Last week, the Biosimilars Council filed an amicus brief in support of Apotex’s petition. The brief is available here….
As we previously reported, Celltrion has moved to dismiss Janssen’s claim of infringement of the ’083 patent, the sole remaining patent in the case since the district court entered partial final judgment with respect to the ’471 patent. On October 7, 2016, Judge Wolf issued an order instructing the parties,…