On May 22, 2023, Boehringer Ingelheim announced that the FDA has approved the Cyltezo Pen, a new autoinjector option for Cyltezo (adalimumab-adbm). According to a previous announcement from Boehringer Ingelheim, Cyltezo is an FDA-approved Interchangeable biosimilar to Humira (adalimumab) and its commercial license will begin on July 1, 2023. Initially…
On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. submitted a Citizen Petition to the FDA, requesting that it interpret the term “strength” in section 351(k) of the Public Health Service Act for parenteral solutions to mean “total drug content,” without regard to concentration. Boehringer Ingelheim maintains that this correction would…
Today, AbbVie and Boehringer Ingelheim (“BI”) announced that they reached a resolution of all intellectual property-related litigation concerning BI’s proposed biosimilar Cyltezo® (adalimumab-adbm). According to the press releases, AbbVie has granted BI a non-exclusive license to AbbVie’s intellectual property relating to adalimumab in the United States. All U.S. litigation pending between the parties…
Magistrate Judge Lloret of the District of Delaware recently issued two discovery rulings in the ongoing AbbVie v. Boehringer Ingelheim (“BI”) litigation. Grant of BI’s Motion To Compel Production Of Pre-litigation Disclosures and Settlement Agreements In an opinion issued on April 11, 2019, the court granted BI’s motion to compel production…
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®…
We have recently reported on multiple discovery rulings in the ongoing AbbVie v. Boehringer Ingelheim litigation concerning Boehringer Ingelheims’s (“BI’s”) aBLA for Cyltezo™ (adalimumab-adbm), a biosimilar version of AbbVie’s Humira® (adalimumab) product. On June 14, 2018, Magistrate Judge Lloret issued two additional opinions regarding discovery in the case. In the first opinion, the Court granted-in-part…
We have covered the ongoing AbbVie v. Boehringer Ingelheim litigation concerning Boehringer Ingelheims’s (“BI’s”) aBLA for Cyltezo™ (adalimumab-adbm), a biosimilar version of AbbVie’s Humira® (adalimumab) product, including the grant of a recent motion to compel discovery regarding BI’s unclean hands defense. Magistrate Judge Lloret issued two additional orders regarding discovery in that case….
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…