Yesterday, the Federal Circuit issued a final decision in Genzyme Therapeutic Prods. v. Biomarin Pharms., No. 2015-1720 case affirming two PTAB IPR final decisions invalidating as obvious the claims of U.S. Patent Nos. 7,351,410 and 7,655,226, which are directed to the treatment of Pompe’s disease with injections of human acid…
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…
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…
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…
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…
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…
We previously reported on Sandoz’s aBLA for a biosimilar of Amgen’s ENBREL (etanercept) and the related BPCIA litigation. The FDA’s Arthritis Advisory Committee announced this morning that it will hold a public advisory committee meeting on July 13, 2016 to discuss Sandoz’s etanercept biosimilar. According to the announcement, anyone wishing to…
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,…
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…
Today, the FDA filed a notice for comments on guidance requesting that biologic applicants propose a suffix composed of four lowercase letters for use as the distinguishing identifier included in the proper name designated by FDA at the time of licensure for biological products licensed under the 42 U.S.C. 262(a)…