As we’ve previously reported, Sandoz is seeking approval of an aBLA for its proposed biosimilar to Neulasta® (pegfilgrastim), which is currently the subject of a BPCIA litigation (Civil Action No. 3:16-cv-02581 (N.D. Cal.)) against Amgen, the reference product sponsor. Today, Sandoz announced that it has received a complete response letter…
United States: On July 13, an FDA advisory committee voted to recommend approval of Sandoz’s biosimilar to Enbrel® (etanercept). The recommendation was to approve the biosimilar for all indications for which Enbrel® is currently approved: rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis. Asia: On July…
Last month, Missouri Governor Jay Nixon signed into law Senate Bill 875, allowing pharmacists filling prescriptions for brand name biological products to substitute a less expensive biosimilar product if the biosimilar has been approved by the FDA to be an interchangeable biological product. Missouri is now the twenty second state…
FDA denied citizen’s petitions from Abbvie, the UAW Retiree Medical Benefits Trust, and the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations requesting that FDA impose particular labeling requirements on biosimilar applicants. FDA said it will continue to determine appropriate labeling on a case-by-case basis and invited the parties…
An FDA advisory panel unanimously voted to recommend approval of Amgen’s ABP501 biosimilar of AbbVie’s Humira (adalimumab) on Tuesday. Likewise, an FDA advisory panel is scheduled to consider approval of Sandoz’s GP2015 biosimilar of Amgen’s Enbrel (etanercept) today. Our previous coverage noted that the FDA made a preliminary determination that ABP501 is “highly similar”…
Merck Sharp & Dohme Corp. has challenged Genentech’s U.S. Patent No. 7,923,221 (Cabilly III) with a complaint for declaratory judgment in the Central District of California. The patent relates to methods to produce antibody products. Merck received FDA approval to market Keytruda® (pembrolizumab) for treating certain melanomas and lung cancers, and…
The Board has instituted IPR2016-00408 and IPR2016-00409 on AbbVie Biotechnology’s U.S. Patent No. 8,889,135, which covers methods of treating rheumatoid arthritis with a human anti-tumor necrosis factor α antibody. This patent relates to AbbVie’s Humira®. IPR2016-00172 filed by Coherus BioSciences Inc. was also instituted against this patent earlier this year.
Merck Sharp & Dohme Corp. has filed an IPR petition on U.S. Patent No. 6,331,415. This patent has been challenged several times over the past year with mixed results: IPR2015-01624 (instituted); IPR2016-00383 (not instituted); IPR2016-00460 (joined with IPR2015-01624); and IPR2016-0710 (petition pending).
A preliminary review by FDA staff found that Amgen Inc.’s biosimilar of AbbVie Inc.’s Humira® showed potency and safety similar to the original product. Humira® (adalimumab) is the top-selling drug in the world and is used to treat autoimmune conditions including rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. A panel…
Tuesday’s Federal Circuit opinion in Amgen v. Apotex is already being picked up and analyzed in other BPCIA litigation: in Amgen v. Hospira, Hospira has submitted the Federal Circuit’s opinion to the District Court for the District of Delaware (J. Andrews) in connection with its pending motion to dismiss Amgen’s…