Tagged as: Adalimumab

Senators Ask FTC To Examine Biosimilar Patent Settlements For Antitrust Violations

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…

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Court Grants BI Motion to Compel Discovery in Adalimumab Litigation

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…

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Paper reports on administration of adalimumab biosimilar using an autoinjector

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…

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AbbVie Reports Positive Phase 3 Results Showing Small Molecule Upadacitinib Is Superior To Adalimumab For RA

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…

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Coherus Files Two More Petitions for IPR of Abbvie's '619 Humira Patent

Coherus Biosciences has filed two petitions for inter partes review of Abbvie’s U.S. Patent 9,085,619.  (IPR2017-01008 and IPR2017-01009).  Coherus recently filed four other petitions for inter partes review of the ‘619 patent, as we’ve reported.  Those cases are pending an institution decision. According to the petitions, the ‘619 patent is drawn…

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