As we previously reported, Sandoz appealed the PTAB’s decision not to institute an IPR regarding AbbVie’s U.S. Patent No. 9,512,216, which relates to a method for treating moderate to severe chronic plaque psoriasis using adalimumab. Last month, the Federal Circuit ordered Sandoz to show cause why the appeals should not be dismissed for lack…
Guangzhou-based biopharmaceutical company Bio-Thera Solutions recently announced that the China National Drug Administration has accepted for review the BLA for BAT1406, a proposed Humira® (adalimumab) biosimilar. Bio-Thera states that the BAT1406 BLA contains clinical data from a pharmacokinetic/pharmacodynamic (PK/PD) trial and a Phase III confirmatory safety and efficacy study in…
Earlier this month, Clover Biopharmaceuticals, Celltrion, and JHL Biotech provided updates on their respective biosimilar clinical trials. A summary of these developments is below. Clover Biopharmaceuticals announced the beginning of their Phase 1 trial of SCB-808, a proposed biosimilar to Enbrel (etanercept). According to Clover, the trial is designed to…
Today, AbbVie sued Sandoz regarding its proposed biosimilar to HUMIRA (adalimumab) in the District of New Jersey. The suit alleges infringement under the BPCIA of U.S. Patent Nos. 9,187,559 and 9,750,808. The ‘559 patent is directed to methods of administration of adalimumab for treatment of idiopathic inflammatory bowel diseases. The ‘808…
The European Medicines Agency (EMA) recently published highlights from the meeting of the Committee for Medicinal Products for Human Use (CHMP) on July 23-26, 2018, reporting that CHMP had adopted positive opinions, recommending the granting of marketing authorisation, for three biosimilar medicines: (1) Fujifilm Kyowa Kirin Biologics (FKB) and Mylan’s…
Last week the European Commission granted marketing authorization for two biosimilars. First, Sandoz, a division of Novartis, announced on July 27 that it had received marketing authorization for Hyrimoz, its adalimumab biosimilar to AbbVie’s Humira. Authorization was granted for all indications of the reference biologic, including rheumatoid arthritis, plaque psoriasis,…
AbbVie raised its 2018 earnings guidance last week, based in part on increased sales of Humira (adalimumab). In its report on its second-quarter 2018 financial results, AbbVie noted a 10% increase in U.S. sales of Humira in the quarter, and stated during the earnings call that it expected U.S. sales…
This morning AbbVie announced that it has entered into patent license agreements with Mylan over its proposed biosimilar of Humira® (adalimumab). AbbVie states that it has agreed to “grant Mylan a non-exclusive license on specified dates to AbbVie’s intellectual property relating to HUMIRA in the United States and in various…
Pending U.S. District Court BPCIA Litigations Resolved U.S. District Court BPCIA Litigations Last updated: May 1, 2025
United States Senators Chuck Grassley (R-Iowa) and Amy Klobuchar (D-Minn.) recently sent a letter to Federal Trade Commission (FTC) Chairman Joseph Simons urging the “FTC to examine global patent settlements relating to biosimilars to ensure they are not in violation of antitrust laws.” According to the Senators, “biologics constitute a…