On July 20, Pennsylvania Governor Tom Wolf signed into law Senate Bill 514, which allows pharmacists to substitute for a brand name biological product a less expensive biosimilar product that has been deemed interchangeable by the FDA. Pennsylvania is the twenty third state to enact such a law. In particular,…
We previously reported on collaborations between Amgen and Allergan on oncology-related biosimilars. On July 21, Amgen and Allergan announced results of a Phase III trial for their ABP 980 product, which is being developed as a biosimilar to Genentech’s Herceptin® (trastuzumab). According to the companies’ press release, the trial confirmed…
As we previously reported, on July 5, the Federal Circuit affirmed the district court’s grant of a preliminary injunction enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it receives FDA licensure, gives Amgen a post-licensure notice of commercial marketing, and then waits for 180 days to…
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.