The Big Molecule Watch team looks forward to seeing you during the next couple of days at American Conference Institute’s 7th Annual Biosimilars Summit. Our colleague, Goodwin partner Sarah Frederick, will address how to distinguish a biosimilar product from the reference product while minimizing the risk of legal claims that may…
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…
The FDA has extended the public comment period for its draft guidance “Labeling for Biosimilar Products: Guidance for Industry” by 60 days, to August 2, 2016: https://www.federalregister.gov/articles/2016/06/06/2016-13223/labeling-for-biosimilar-products-draft-guidance-for-industry-availability-extension-of-comment
Last month, the governor of Arizona signed a bill into law allowing pharmacists to automatically substitute a biosimilar for a reference branded biologic. Arizona continues the recent trend of states enacting biosimilar automatic substitution laws, including, for example, New Jersey and Oregon. Under the new Arizona law, from December 31, 2016 onward,…
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)…