Today, in the AbbVie v. Amgen adalumimab case, Judge Robinson entered a stipulated order that dismissed Count XI of AbbVie’s Complaint. With its Count XI, AbbVie sought an order compelling Amgen to comply with the “notice of commercial marketing” provision of 42 U.S.C. § 262(l)(8)(A). In the Complaint, AbbVie had…
The Irish Times reports that Pfizer will be cutting the price of Enbrel® (etanercept) on November 1st. Pfizer is cutting its price to comply with Ireland’s Framework Agreement on the Supply and Pricing of Medicines (the “Framework Agreement”), which, starting August 1, 2016, set new pricing rules for medicines supplied to or reimbursed…
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…
Last Thursday, October 20, the FDA held a scheduled public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA). The FDA heard from a wide spectrum of stakeholders, including patient/public health advocates, healthcare professionals, and industry representatives. As we previously reported, the FDA had committed to publishing a draft…
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…
As we previously reported, on September 26, 2016, the district court in Janssen v. Celltrion entered partial final judgment that the ’471 patent, asserted by Janssen, was invalid. Today, Janssen filed a notice that they are appealing the district court’s judgment to the Federal Circuit. Meanwhile, Celltrion’s partner Pfizer announced last week that it will begin shipping…
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.