The FDA has accepted Genentech’s BLA for a subcutaneous formulation of rituximab. The drug is indicated to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, moderate to severe rheumatoid arthritis, Wegener’s granulomatosis and microscopic polyangiitis. According to Genentech, its formulation uses a recombinant human hyaluronidase enzyme from Halozyme, approved and marketed under…
As we previously reported, Amgen filed an appeal brief challenging the district court’s resolution of its discovery dispute with Hospira and addressing the issue of whether the Federal Circuit had jurisdiction to hear the appeal. On October 25, 2016, Hospira filed a responsive appeal brief asserting that (1) the Court does not…
Pfizer Inc. announced yesterday that it is discontinuing global clinical development of bococizumab, a monoclonal antibody inhibitor of PCSK9 that was being investigated as a lipid-lowering drug. After completing the last of six planned clinical efficacy studies of bococizumab, Pfizer stated that it observed that the drug’s lipid-lowering activity declines…
Last week, Boehringer Ingelheim announced that BI 695501, a proposed biosimilar of Humira (adalimumab), met the primary efficacy endpoint in a pivotal Phase III study comparing BI 695501 to Humira for treatment of patients with rheumatoid arthritis. The company says that the results of the study show that BI 695501…
According to The Korea Herald, the South Korean biopharma company Celltrion submitted their Herceptin biosimilar, Herzuma, to the European Medicine Agency for approval. Herzuma, a biosimilar to Roche’s breast cancer drug Herceptin (trastuzumab), was approved in Korea two years ago for the treatment of metastatic breast cancer, early stage breast…
Today, in the AbbVie v. Amgen adalumimab case, the parties filed a joint proposed scheduling order. The parties jointly proposed a bench trial commencing the week of November 4, 2019, with completion of fact discovery by January 15, 2018 and expert discovery by May 24, 2019. AbbVie noted that the…
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…