On July 22, 2016, Australia’s Therapeutic Goods Administration approved Samsung Bioepis’s biosimilar of Amgen’s Enbrel (etanercept), which is approved for treatment of rheumatoid arthritis. Samsung Bioepis’s product, called Brenzys, will be available as a pre-filled auto-injector and sold in Australia by Merck Sharpe & Dohme, Merck & Co.’s international subsidiary. Samsung…
On July 22, 2016, the District Court for the District of New Jersey granted Sandoz’s motion to dismiss Amgen’s declaratory judgment action related to Sandoz’s biosimilar of Amgen’s Neulasta (pegfilgrastim). As background, Sandoz provided Amgen with required disclosures related to its pegfilgrastim biosimilar under § 262(l)(2) and (l)(3)(B) then sent Amgen a letter waiving receipt…
Epirus Biopharmaceuticals, a biosimilar startup, has filed for Chapter 7 bankruptcy. The Boston-based startup had lost approximately 82% of its value by June of 2016, after an announcement that it would cease working on a biosimilar of Remicade (infliximab) to focus on Soliris (eculizumab) and Actemra (tocilizumab), a cut in…
Cipla has announced that it is investing 1.3 billion South African Rand (approximately 91 million USD) to open a biotech plant in South Africa. According to Cipla’s press release, this will be South Africa’s first state-of-the-art biotech manufacturing facility for the production of biosimilars. The facility will have the necessary…
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…
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”…