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Hearing on Preliminary Injunction in Amgen v. Apotex

Last Thursday, December 3, the U.S. district court for the Southern District of Florida heard oral arguments on Amgen’s motion for a preliminary injunction in Amgen v. Apotex. As we’ve discussed in previous posts (here, here, and here), Amgen is seeking a preliminary injunction to prevent Apotex from launching its…

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FDA’s Interim Response to AbbVie’s Citizen Petition

As we’ve previously reported, AbbVie filed a Citizen Petition on June 2, 2015 demanding that FDA impose particular labeling requirements on biosimilar applicants, and several other entities subsequently submitted comments on AbbVie’s petition.  On December 1, 2015, FDA issued an interim response to AbbVie’s petition indicating that “FDA has been…

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HHS Holds Forum on Affordable Healthcare

On November 20th, the U.S. Department of Health and Human Services (HHS) held a forum entitled “HHS Pharmaceutical Forum: Innovation, Access, Affordability and Better Health.” A list of the speakers and their biographies is available here, and a link to video recordings of the proceedings is available here. The forum…

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European Medicines Agency Recommends Market Authorization for First Etanercept Biosimilar

On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal products for Human Use (CHMP) recommended the granting of a market authorization for Benepali, a biosimilar intended for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis.  This is the second biosimilar antibody drug that…

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Amgen Submits Application for Biosimilar Version of Humira (adalimumab)

Amgen today announced the submission of its first biosimilar application to FDA. The application seeks approval for a biosimilar version of Humira®(adalimumab). As we’ve covered extensively, Amgen is the biologic reference product sponsor and plaintiff in a number of BPCIA cases: Amgen v. Sandoz, Amgen v. Hospira, and Amgen v. Apotex.  This is the first time Amgen has formally appeared on…

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Roundup of Upcoming BPCIA Cases

As we have written about extensively, here, here, and here, the Federal Circuit recently interpreted two key provisions of the BPCIA in Amgen v. Sandoz. Three cases currently pending before District Courts raise related issues and each have the potential to reach the Federal Circuit. In this post, we provide…

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