Earlier this month, Clover Biopharmaceuticals, Celltrion, and JHL Biotech provided updates on their respective biosimilar clinical trials. A summary of these developments is below. Clover Biopharmaceuticals announced the beginning of their Phase 1 trial of SCB-808, a proposed biosimilar to Enbrel (etanercept). According to Clover, the trial is designed to…
On August 6, 2018, STADA Arzneimittel AG (“STADA”) announced that it had acquired a majority stake in BIOCEUTICALS Arzneimittel AG (“BIOCEUTICALS”). According to the press release, STADA is acquiring an additional 35.48 percent of the shares in BIOCEUTICALS from its co-shareholders to bring its total stake to 51.34 percent. BIOCEUTICALS…
Today, AbbVie sued Sandoz regarding its proposed biosimilar to HUMIRA (adalimumab) in the District of New Jersey. The suit alleges infringement under the BPCIA of U.S. Patent Nos. 9,187,559 and 9,750,808. The ‘559 patent is directed to methods of administration of adalimumab for treatment of idiopathic inflammatory bowel diseases. The ‘808…
As we reported here, Pfizer filed an antitrust lawsuit last year against Johnson & Johnson (J&J) in the U.S. District Court for the Eastern District of Pennsylvania alleging that J&J has engaged in an anticompetitive scheme to protect its Remicade® (infliximab) product since Pfizer introduced its competing biosimilar Inflectra (infliximab-dyyb) in 2016. As…
The European Medicines Agency (EMA) recently published highlights from the meeting of the Committee for Medicinal Products for Human Use (CHMP) on July 23-26, 2018, reporting that CHMP had adopted positive opinions, recommending the granting of marketing authorisation, for three biosimilar medicines: (1) Fujifilm Kyowa Kirin Biologics (FKB) and Mylan’s…
Amgen filed a complaint against Apotex today in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 based on Apotex’s aBLAs for filgrastim and pegfilgrastim biosimilars. The ’287 patent issued on January 2, 2018 and is directed to methods of protein refolding in non-mammalian expression systems. According to…
In a letter to FDA last month, the International Generic and Biosimilar Medicines Association (IGBA), which represents member pharmaceutical companies from the USA, Canada, South Africa, India, Jordan, Japan, Europe and Taiwan, requested that FDA “revisit their position and waive the requirement of bridging studies.” Typically, biosimilar sponsors are required…
The United Kingdom’s National Health Service (NHS) recently announced that in its last fiscal year, it had saved $419 million in switching to biosimilar and generic versions of ten expensive drugs. These savings exceeded the $324 million in savings the NHS had forecasted. According to the announcement, most of the…
Last week, FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2019 fiscal year, which runs from October 1, 2018 through September 30, 2019. The FDA determined these rates pursuant to the Food and Drug Administration Reauthorization Act (FDARA), signed into law on August 18, 2017. Among other…
Last week the European Commission granted marketing authorization for two biosimilars. First, Sandoz, a division of Novartis, announced on July 27 that it had received marketing authorization for Hyrimoz, its adalimumab biosimilar to AbbVie’s Humira. Authorization was granted for all indications of the reference biologic, including rheumatoid arthritis, plaque psoriasis,…