According to an announcement by Samsung Bioepis, an additional one-year follow-up study on SB3, a biosimilar candidate referencing Herceptin® (trastuzumab), showed low incidence of cardiac safety events and no statistically significant difference in survival results compared to trastuzumab in patients with HER2-positive early or locally advanced breast cancer. The data…
As we previously reported, in 2017, Pfizer filed an antitrust lawsuit against Johnson & Johnson (J&J) in the U.S. District Court for the Eastern District of Pennsylvania alleging that J&J had engaged in an anticompetitive scheme relating to its Remicade® (infliximab) product. Yesterday, Walgreen and Kroger filed an antitrust lawsuit…
On June 4, 2018, FDA announced the availability of a new draft guidance on formal meetings with FDA concerning the development and review of biosimilar or interchangeable biological products. The draft guidance, titled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products,” is available here. FDA also…
On November 11, 2017, Pfizer, Inc. filed a petition for inter partes review (IPR) of Biogen and Genentech’s US Patent No. 8,545,843, which relates to a method of treating vasculitis with rituximab. (IPR2018-00086.) On May 31, 2018, the PTAB denied institution of this IPR. Separately, on June 4, 2018, Pfizer filed…
Several biopharmaceutical developers recently announced significant regulatory submission activity in connection with biosimilar products in their pipelines. In addition to yesterday’s news about the U.S. FDA’s approval of Mylan and Biocon’s Fulphila™ (pegfilgrastim-jmdb) biosimilar product, below are some highlights: On June 1, the Committee for Medicinal Products for Human Use…
Today, the U.S. FDA announced that it has approved Mylan’s aBLA for Fulphila™ (pegfilgrastim-jmdb), a biosimilar of Amgen’s Neulasta®. This approval marks the eleventh FDA licensure of a biosimilar product under the BPCIA regulatory scheme, following last month’s approval of Pfizer’s Retacrit™ (epoetin alfa-epbx), and the first time the FDA…
For certain drugs with serious risks, the FDA may require drug developers to submit a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug or biologic outweigh its risks. For an overview on REMS click here. We have previously reported that FDA received numerous inquiries from generic…
On May 29, 2018, a week-long bench trial began before Judge Andrews in Sanofi-Aventis U.S. LLC v. Merck Sharpe & Dohme Corp. in the District of Delaware. As we reported here, Sanofi had sued Merck for patent infringement based on Merck’s proposed follow-on versions of Sanofi’s Lantus® and Lantus® SoloSTAR® ([rDNA origin]…
Earlier this month, the journal of Expert Opinion on Drug Delivery published results from a clinical study of BI 695501, an adalimumab biosimilar, using an autoinjector (AI). BI 695501 is a self-injectable adalimumab biosimilar that according to the publication has “demonstrated PK bioequivalence and similar clinical efficacy, safety, and immunogenicity with…
Below are some recent regulatory developments in the biologics space. As we previously reported, USP has been considering a revision to the naming conventions for the titles of biologics product monographs. Following comments from FDA, USP announced that it would not make any changes absent stakeholder consensus. Last month, USP…