The European Medicines Agency’s (EMA) Committee for Medicinal Use Products (CHMP) recently recommended approval of six new biosimilars. The CHMP recommended approval of four biosimilars developed by Celltrion: (1) AVTOZVMA (tocilizumab), for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, CAR-T cell-induced…
Samsung Bioepis’ PYZCHIVA On July 1, Samsung Bioepis Co., Ltd. announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab). PYZCHIVA is approved for the treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active…
On April 13, 2022, Amneal Pharmaceuticals, Inc. announced that the FDA approved its BLA for bevacizumab-maly, a biosimilar of Roche’s AVASTIN. The product will be marketed under the proprietary name ALYMSYS and represents the third bevacizumab biosimilar approved in the U.S, following Pfizer’s ZIRABEV (bevacizumab-bvzr) in 2019 and Amgen’s MVASI…
Amneal Pharmaceuticals, Inc., a fully integrated pharmaceutical company headquartered in Bridgewater, NJ, announced last week that the U.S. FDA has accepted its aBLA seeking approval of a biosimilar of Avastin® (bevacizumab). This biosimilar was developed in collaboration with Spain-based biopharmaceutical company mAbxience, which had obtained approval earlier this year to…
In March 2021, researchers from Harvard Medical School, Harvard University, and Brigham and Women’s Hospital published a white paper exploring the link between entry of biosimilars under The Biological Price Competition and Innovation Act (BPCIA) and moderation in drug prices driven by market competition. The white paper studied the price and…
Investigators presented two studies on Monday at the American Society of Hematology Annual Meeting and Exposition (ASH) showing the potential for significant cost-savings by switching to biosimilar pegfilgrastim from the pegfilgrastim on-body injector (PEG-OBI). In one study, investigators demonstrated a potential for savings from a conversion to several biosimilar filgrastim…
Below are some highlights from third quarter 2020 earnings reports recently released by biologics and biosimilars companies: Biogen reported a decrease in year over year (YoY) revenue of 6% to $3.4 billion, but a 13% increase to $208 million in biosimilar revenue. It reported the following YoY revenue for each…
As we previously reported, earlier this year Kashiv Biosciences filed two inter partes review (IPR) petitions challenging certain claims of Amgen’s U.S. Patent Nos. 8,940,878 and 9,643,997, which are directed to methods to purify proteins expressed in a non-native soluble form in a non-mammalian expression system. Amgen is asserting the ’878 and…
This morning, the Federal Circuit issued a precedential opinion affirming the district court’s judgment of non-infringement in favor of Sandoz in its BPCIA litigation against Amgen concerning Sandoz’s Zarxio® (filgrastim-sndz) biosimilar product and proposed pegfilgrastim biosimilar. As we previously reported, in December 2017 the Northern California district court granted summary…
U.S. Patent No. 9,856,287, which is directed to a protein refolding method, is one of the patents-in-suit in the pending Amgen v. Adello (filgrastim) BPCIA litigation and the sole patent-in-suit in the pending Amgen v. Apotex (filgrastim and pegfilgrastim) BPCIA litigation. As we previously reported, in November 2018, Adello and…