In a complaint filed yesterday, the State of California sued AbbVie, Inc. based on an alleged kickback scheme in connection with AbbVie’s Humira® (adalimumab). The complaint alleges that AbbVie violated the Insurance Frauds Prevention Act (“IFPA”) by providing kickbacks to health providers throughout California. Specifically, AbbVie allegedly indirectly paid healthcare…
On September 12, 2018, Boehringer Ingelheim announced positive results from a Phase III clinical trial for its approved adalimumab biosimilar, Cyltezo®. The clinical trial compared the efficacy, safety and immunogenicity of Cyltezo® and Humira® in patients with moderate-to-severe chronic plaque psoriasis. According to Boehringer Ingelheim, the study confirmed equivalence of Cyltezo®…
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…
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…
On Monday, Magistrate Judge Lloret, who is visiting the U.S. District Court for the District of Delaware from the Eastern District of Pennsylvania, granted Boehringer Ingelheims’s (“BI’s”) motion to compel discovery relating to its unclean hands defense in the ongoing AbbVie v. Boehringer Ingelheim litigation concerning BI’s aBLA for a biosimilar version of AbbVie’s…
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…
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…
AbbVie recently announced positive results for upadacitinib, a small molecule Janus Kinase (JAK) inhibitor, in a phase 3 clinical trial of patients with rheumatoid arthritis (RA). According to AbbVie, upadacitinib met all primary and secondary endpoints in the study, including superiority versus adalimumab, the anti-TNFα antibody that Abbvie markets as…
We previously posted that in August 2017, Samsung Bioepis’ adalimumab biosimilar, SB5 (also known as Imraldi®), was granted marketing authorization by the European Commission. In September, it also won approval from the South Korean Ministry of Food and Drug Safety. SB5 is a biosimilar for Humira®, which is approved for…