Here are our picks for the most significant U.S. regulatory developments related to biosimilars in 2018: 1. FDA Releases Biosimilars Action Plan In July, FDA released the Biosimilar Action Plan (BAP), which outlines the Administration’s proposed next steps to help reduce the costs of healthcare by expediting the development of…
Today, the FDA approved Celltrion’s Herzuma (trastuzumab-pkrb), a biosimilar that references Genentech’s Herceptin (trastuzumab), for the treatment of patients with HER2-overexpressing breast cancer, in accordance with the FDA-approved label. Celltrion’s product is the subject of ongoing BPCIA litigation, pending before the District of Delaware. This marks the seventh biosimilar the FDA has approved…
Today, the FDA issued four new biosimilar guidances, as well as a proposed rule. According to a statement by FDA Commissioner Scott Gottlieb, two of the guidance documents—the draft guidance titled “The ‘Deemed to be a License’ Provision of the BPCI Act Questions and Answers” and the final guidance “Interpretation…
On Wednesday, the FDA approved the first biosimilar to Genentech’s RITUXAN®. The FDA’s press release noted that Teva and Celltrion’s biosimilar TRUXIMA® (rituximab-abbs) is the first biosimilar to be approved in the U.S. for the treatment of non-Hodgkin’s lymphoma. TRUXIMA® is indicated for treatment of adult patients for: Relapsed or…
Today, Coherus BioSciences announced that the U.S. FDA has approved Udenyca™ (pegfilgrastim-cbqv), its biosimilar of Amgen’s Neulasta®, for patients with cancer receiving myelosuppressive chemotherapy. Udenyca™, which received marketing authorization in Europe in September, is Coherus’ first biosimilar to obtain approval in the United States. Udenyca™ is the fourteenth biosimilar to…
The FDA announced today that it has approved Sandoz’s biosimilar Hyrimoz (adalimumab-adaz). The FDA had previously approved adalimumab biosimilars from Amgen and Boehringer Ingelheim. Sandoz’s global settlement with AbbVie regarding Hyrimoz provides Sandoz with a U.S. entry date of September 30, 2023, whereas Amgen is permitted an earlier U.S. launch,…
Below are some recent updates regarding U.S. regulatory submissions and a launch in connection with biosimilar products: On September 27, 2018, Samsung Bioepis announced that the U.S. FDA has accepted its aBLA for SB5, a proposed biosimilar of Humira® (adalimumab), which Bioepis submitted to the FDA in July. According to…
The Association for Accessible Medicines (AAM) and Biosimilars Council submitted comments to FDA two weeks ago regarding “the biosimilars action plan and ways to facilitate competition” in the biosimilars industry. Collectively referred to in the comments as AAM, and the “sole association representing America’s generic pharmaceutical sector in the United States,”…
Last week, FDA published its draft guidance on civil money penalties relating to the ClinicalTrials.gov data bank to the federal register. The guidance addresses how the FDA Centers (CDER, CBER, and CDRH, for drug, biological, and device products, respectively) identify whether parties have failed to submit required clinical trial registrations, results,…
On August 22, 2018, Pfizer submitted a citizen petition to the Food and Drug Administration requesting “guidance clarifying appropriate sponsor communications about the nature and properties of biosimilar products.” Specifically, Pfizer petitioned FDA to clarify what constitutes a false and misleading communication with respect to the safety and effectiveness of biosimilars relative…