As we previously reported, on June 3, 2022, Genentech filed a complaint against Tanvex in the U.S. District Court for the Southern District of Florida, alleging infringement of three patents under the BPCIA based on Tanvex’s submission of an aBLA for TX05, a proposed biosimilar of HERCEPTIN (trastuzumab). The three…
Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD). Teva entered into a strategic partnership with Bioeq AG for the exclusive commercialization of ranibizumab. According to the press release, RANIVISIO (ranibizumab) will be the first…
Last week Samsung Bioepis and Organon announced FDA approval of their citrate-free, high-concentration (100 mg/ml) HUMIRA biosimilar, HADLIMA (adalimumab-bwwd). HADLIMA was previously approved by FDA as a low concentration (50 mg/ml) formulation in July 2019. The low-concentration product has been available in various markets outside the United States, with over…
The Seventh Circuit issued this week a long-awaited opinion in the HUMIRA antitrust litigation, UFCW Local 1500 Welfare Fund v. AbbVie Inc., Case No. 20-2402. The appeal is from the Northern District of Illinois’s dismissal of a proposed class action alleging that AbbVie, Inc. created a “patent thicket” around HUMIRA to block…
On July 11, 2022, Teva filed a cert petition with the Supreme Court, seeking review of the Federal Circuit’s split per curiam opinion holding that Teva’s label for its generic drug Coreg induced doctors to infringe a GSK method-of-use patent, despite having a “skinny” label carving out the sole patented…
On June 3, 2022, the PTAB instituted inter partes review of U.S. Patent No. 9,750,752 (“the ’752 patent”), owned by Chugai and Roche. Fresenius filed a petition for inter partes review of claims 1-16 of the ‘752 patent, directed to methods of treating giant cell arteritis by subcutaneously administering tocilizumab. …
Genentech filed a complaint yesterday against Tanvex in the U.S. District Court for the Southern District of California, alleging infringement of three patents under the BPCIA based on Tanvex’s submission of an aBLA for TX05, a proposed biosimilar of HERCEPTIN (trastuzumab). Genentech asserts that Tanvex’s process for manufacturing TX05 infringes…
Amneal announced today that the U.S. Food and Drug Administration has approved its Biologics License Application for FYLNETRA™ (pegfilgrastim-pbbk), a biosimilar referencing NEULASTA®. FYLNETRA, developed in collaboration with Kashiv Biosciences, LLC, is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which…
The District of Delaware has issued a scheduling order, setting a trial for April 2024, in Bristol Myers Squibb’s (BMS) patent case against AstraZeneca. BMS filed its complaint against AstraZeneca on March 17, 2022, alleging infringement of eight patents related to anti-PD-L1 antibodies. According to BMS, the case “relates to…
Last week Pfizer filed a lawsuit in a federal court of Australia against respondents Samsung Bioepis, Merck, Sharp & Dohme, Organon, and Arrow, to halt sales of their biosimilar BRENZYS (etanercept). Pfizer alleges that the respondents infringe Australian Patent No. 2005280034, titled “Production of polypeptides,” with claims directed to cell…