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The FDA has extended the public comment period for its draft guidance “Labeling for Biosimilar Products: Guidance for Industry” by 60 days, to August 2, 2016: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)…
On May 31, 2016, the FDA issued a notice that FDA’s Center for Biologics Evaluation and Research (FDA/CBER) intends to “enhance technical collaboration and cooperation between the FDA, WHO, and its member states to facilitate strengthening regulatory capacity and support product development and standardization activities to increase access to safe…
The Committee on Internal Market and Consumer Protection of the European Parliament has adopted its report on the “Single Market Strategy” – a strategy that aims to consolidate industries in European countries under one umbrella. Included in the report is a section on “consolidating Europe’s intellectual property framework.” The report…
On May 30, the European Commission granted marketing authorization for FLIXABI,® an infliximab biosimilar developed by Samsung Bioepis, the joint venture between Biogen and Samsung Biologics. See here for press coverage.
As we previously reported, in late 2015, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations jointly submitted a Citizen Petition asking the FDA to require biosimilar product labeling to: State that the product has been approved as a biosimilar for stated indications and…
On May 16, 2016, Sorrento Therapeutics announced successful results from a Phase 2 and 3 clinical study for a biosimilar to Xolair. Xolair (omalizumab) is marketed by Genentech and Novartis to treat allergic asthma and chronic idiopathic urticaria (a chronic skin condition). Sorrento’s biosimilar product, dubbed STI-004, proved to be…