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…
As we previously reported, UAW Retiree Medical Benefits Trust and affiliated funds filed a Citizen Petition on November 2, 2015 asking FDA to adopt a “same labeling” approach for biosimilar labeling. On May 19, 2016, FDA issued an interim response indicating that “FDA has been unable to reach a decision…
As we reported earlier, Amgen recently filed suit under the BPCIA against Sandoz and Lek Pharmaceuticals in the Northern District of California. Amgen alleges that Sandoz’s submission of an aBLA for its pegfilgrastim product (a biosimilar of Neulasta®) infringed two of Amgen’s patents under 35 U.S.C. § 271(e)(2)(C). Amgen also…
Today, the PTAB instituted IPR proceedings on claims 1-5 of U.S. Patent No. 8,889,135, drawn to a method of treating a rheumatoid arthritis patient with a TNFα-inhibitor. Humira®, marketed by Abbvie, is allegedly covered by the claims of the ’135 patent. The IPR petition was filed by Coherus Biosciences, Inc….
On June 14th, Rob Cerwinksi will speak at American Conference Institute’s 7th Annual Biosimilars Summit. Rob will address how to distinguish a biosimilar product from the reference product while minimizing the risk of legal claims that may arise from the promotion. Goodwin and the Big Molecule Watch team have a…