On August 31, 2022, the PTAB instituted two inter partes reviews of Chugai and Roche’s tocilizumab patents challenged by Celltrion, adding to the growing list of IPRs instituted against the tocilizumab patent estate. We have been tracking the IPRs instituted against tocilizumab-related patents (see our last post, PTAB Institutes Sixth…
On August 30, 2022, Outlook Therapeutics, Inc. announced that it has re-submitted its Biologics License Application (BLA) to the FDA for ONS-5010, “an investigational ophthalmic therapy which, if approved, will be branded as LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).” As we previously reported, Outlook…
On August 23, 2022, Amgen announced positive top-line results from a phase 3 study of ABP 959, Amgen’s proposed biosimilar to SOLIRIS (eculizumab). Amgen noted that the study was “a randomized, double-blind, active-controlled, two-period crossover Phase 3 study evaluating the efficacy and safety of ABP 959, a biosimilar candidate to…
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…
Alvotech announced this week the initiation of a confirmatory patient study for AVT03 (denosumab), a biosimilar candidate to PROLIA® and XGEVA®, to demonstrate clinical similarity to PROLIA® in terms of efficacy, safety, immunogenicity, and pharmacokinetics in postmenopausal women with osteoporosis. According to Alvotech, the results from this trial will be…
The FDA is hosting a virtual public workshop on September 19, 2022 on “Increasing the Efficiency of Biosimilar Development Programs.” The workshop will focus on comparative clinical studies and “discuss possible innovative ideas to improve the efficiency of biosimilar development.” The workshop will include detailed discussion on the statistical methods…
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…
This week Formycon AG (“Formycon”) announced positive preliminary efficacy and safety data from the VESPUCCI Phase III clinical trial for FYB202, Formycon’s biosimilar version of STELARA (ustekinumab). The Phase III study was a multi-center, randomized, double-blinded, comparative study of patients with moderate to severe psoriasis vulgaris (plaque psoriasis). The clinical…
On August 2, 2022, Senator Thom Tillis (R-NC) released a proposed bill to further codify what is and is not proper subject matter for a patent claim at the United States Patent and Trademark Office (USPTO). The Patent Eligibility Restoration Act of 2022, Senate Bill 4734, amends 35 U.S.C. s….
The Big Molecule Watch is monitoring clinical trial activities involving adalimumab. Here we report on three recent studies with adalimumab biosimilars for treating psoriasis, inflammatory bowel disease, Crohn’s disease and ulcerative colitis. In July 2022, clinical trial data was published from a real-life retrospective observational study of pediatric (<18 years)…