During the European Academy of Dermatology and Venereology Congress in Vienna, Johnson & Johnson presented data on their experimental psoriasis drug, guselkumab. Guselkumab targets a protein, interleukin-23, which is specifically involved with the skin’s immune responses. Guselkumab cleared or nearly cleared the skin of 81% of patients during a final-stage…
Amgen has filed its answer in response to AbbVie’s complaint alleging infringement of 10 patents that allegedly cover Amgen’s recently-approved adalimumab biosimilar, Amjevita (formerly known as ABP501). Amgen asserts that AbbVie’s responses to its aBLA and required disclosures were deficient. Specifically, Amgen asserts that AbbVie did not provide an adequate…
On September 23, the FDA denied a citizen petition from AbbVie submitted to the FDA on April 2, 2012, requesting that the FDA not implement the BPCIA as to any applications for biosimilar products referencing Humira (adalimumab), or any other product for which the BLA was submitted to the FDA…
Samsung Bioepis is reportedly seeking regulatory approval to sell a biosimilar version of Humira® (adalimumab) in South Korea. Also, in July 2016, Samsung Bioepis reported that the EMA had accepted its Marketing Authorization Application for SB5, an adalimumab biosimilar. As we recently reported, Samsung Bioepis already has approved biosimilar applications for etanercept and…
Below is a brief summary of each of the U.S. patent litigations concerning a proposed or approved biosimilar product. Please also consult our BPCIA Litigation Summary Chart for additional details.
As we reported last week, on Thursday, August 4, AbbVie sued Amgen seeking an injunction to prevent Amgen from launching its biosimilar version of AbbVie’s Humira. The complaint alleges that Amgen’s biosimilar infringes 61 U.S. patents (and five pending U.S. patent applications that have since been allowed), but that AbbVie has…
AbbVie has filed a complaint against Amgen related to AbbVie’s Humira (adalimumab). The complaint asserts patent infringement and also seeks a declaratory judgment to compel Amgen to comply with the BPCIA’s notice of commercial marketing provision. Stay tuned to Big Molecule Watch for more details later today.
Today, AbbVie announced growth in Humira (adalimumab) sales to $4.15 billion worldwide in the second quarter, a 17.4% increase over the same quarter in 2015. On June 30th, AbbVie received FDA approval for a 10th indication for Humira: non-infectious intermediate, posterior and panuveitis in adults, which can severely impact vision. …
FDA denied citizen’s petitions from Abbvie, the UAW Retiree Medical Benefits Trust, and the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations requesting that FDA impose particular labeling requirements on biosimilar applicants. FDA said it will continue to determine appropriate labeling on a case-by-case basis and invited the parties…
An FDA advisory panel unanimously voted to recommend approval of Amgen’s ABP501 biosimilar of AbbVie’s Humira (adalimumab) on Tuesday. Likewise, an FDA advisory panel is scheduled to consider approval of Sandoz’s GP2015 biosimilar of Amgen’s Enbrel (etanercept) today. Our previous coverage noted that the FDA made a preliminary determination that ABP501 is “highly similar”…