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…
Samsung Bioepis Co., Ltd., announced that the FDA has accepted its first biosimilar application submitted in the United States. The candidate, SB2, references Janssen’s Remicade® (infliximab), which treats several ailments, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and psoriasis. Remicade® had over ten billion dollars in sales in 2014. As…
As we previously reported, the PTAB instituted IPR on U.S. Patent 8,889,135, which is drawn to a method of treating rheumatoid arthritis (“RA”) with Humira®, a TNFα-inhibitor. Claim 1 is directed to “A method for treating rheumatoid arthritis in a human subject, comprising administering subcutaneously to a human subject having…
As we covered in a previous post, following the Federal Circuit’s decision in Amgen v. Sandoz, Sandoz filed a petition for a writ of certiorari asking the Supreme Court to review the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing” provision. Sandoz’s petition also asks the Court to consider whether the Federal…
The District Court for the District of Massachusetts (Judge Wolf) yesterday decided two pending motions in Janssen v. Celltrion: Plaintiffs’ motion to stay litigation on the ‘471 patent (covering infliximab) pending appeal of the PTAB’s decision invalidating the patent; and Plaintiffs’ motion to amend the protective order to permit them to file…