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PTAB Institutes IPRs on Two More Humira Patents

Yesterday, the PTAB instituted IPRs on two of Abbvie’s Humira patents, U.S. Patent Nos. 9,017,680 and 9,073,987, which are drawn to dosing regimens for AbbVie’s Humira (adalimumab) for the treatment of rheumatoid arthritis. As previously reported here, the PTAB previously instituted an IPR on related U.S. Patent 8,889,135 based on a petition…

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Samsung Bioepis Presents New Biosimilars Data at EULAR 2016

At the Annual European Congress on Rheumatology (EULAR 2016), held last week in London, Samsung Bioepis presented new clinical data on its etanercept, adalimumab, and infliximab biosimilars.  According to a press release from Biogen, a partner in the Samsung Bioepis joint venture with Samsung BioLogics, Phase III studies for those anti-TNF-α biosimilars have demonstrated that…

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LG Life Sciences Begins Phase III Trials for Humira Biosimilar

LG Life Sciences recently announced the start of phase III clinical trials for its Humira® (adalimumab) biosimilar in South Korea.  The clinical trials will test the effectiveness of the biosimilar on rheumatoid arthritis patients who have shown negative responses to the chemotherapy drug methotrexate.  The trials will also compare the efficacy and safety…

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The Biosimilar Medicines Group Publishes New Guide

The Biosimilar Medicines Group recently published a new edition of their publication, Biosimilar Medicines Handbook, which provides a wealth of updated information on the current progress of biosimilar medicines in the European Union.  The first edition of this guide was published in 2007 when only five biosimilar medications had been…

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Amgen v. Hospira: Amgen Appeals Discovery Ruling

In the Amgen v. Hospira litigation, Amgen has filed a Notice of Appeal relating to Judge Andrew’s oral ruling denying Amgen’s request to compel Hospira to produce certain manufacturing information related to its Epogen® (epoetin alfa) biosimilar product.  We previously covered the discovery dispute in detail here. The appeal was placed on…

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Mylan and Biocon Present Trastuzumab Biosimilar Data at ASCO

On June 3, Mylan N.V.  and Biocon Ltd. presented phase 3 clinical data regarding their trastuzumab product (dubbed MYL-1401O), which is a proposed biosimilar to Genentech’s Herceptin, at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting.  Trastuzumab is indicated for the treatment of HER2-positive metastatic breast cancer patients,…

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Update in Janssen v. Celltrion: Parties Stipulate that Celltrion Will Not Sell Infliximab Biosimilar Before September 15, 2016

We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab) on April 5, 2016.  A year prior to the approval, Janssen filed a motion for summary judgment and preliminary and permanent injunction based on the contention that 42 U.S.C. § 262(l)(8)(A) prohibits Celltrion from commercially marketing its biosimilar…

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