In a letter to the Patent Public Advisory Committee last week, U.S. Patent and Trademark Office Director Andrei Iancu proposed increasing the fees by “roughly 25%” for patent challenges under the America Invents Act, including inter partes review (IPR). The letter states that the proposed increase is in response to a “variety…
Guangzhou-based biopharmaceutical company Bio-Thera Solutions recently announced that the China National Drug Administration has accepted for review the BLA for BAT1406, a proposed Humira® (adalimumab) biosimilar. Bio-Thera states that the BAT1406 BLA contains clinical data from a pharmacokinetic/pharmacodynamic (PK/PD) trial and a Phase III confirmatory safety and efficacy study in…
More than a dozen BPCIA patent litigations are currently pending in various U.S. district courts. Below are some highlights of activity in some of those cases from this month. Genentech v. Amgen (D. Del.): bevacizumab On August 2, 2018, Judge Sleet issued a memorandum in response to the parties’ ongoing…
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…