On May 16, 2022, Alvotech Holdings S.A. (“Alvotech”) announced positive top-line results from a pharmacokinetic (PK) study for AVT04, Alvotech’s proposed biosimilar to STELARA® (ustekinumab). Alvotech notes that the study used “a single dose, 3-arm, parallel design to compare pharmacokinetics, safety, tolerability, and immunogenicity of a single 45mg/0.5mL subcutaneous dose…
Last week, Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has accepted a Priority Review of the supplemental Biologics License Application (sBLA) for DUPIXENT (dupilumab) 300 mg weekly to treat patients aged 12 years and older with eosinophilic esophagitis (EoE). EoE is a chronic, immune-mediated, atopic inflammatory condition of…
The New Jersey district court in the Immunex v. Samsung Bioepis BPCIA litigation entered a Final Judgment and Order of Permanent Injunction on November 3, 2021. As we previously reported, the litigation pertains to ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL. The case had been administratively stayed since January 2020. Judgment…
On May 3, 2021, Sandoz announced that it will begin enrolling patients in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study for its proposed biosimilar to Regeneron’s EYLEA (aflibercept) product. EYLEA is indicated for neovascular age-related macular degeneration (nAMD), diabetic macular oedema, macular oedema secondary to retinal vein…
On March 10, Lannett announced that it received feedback from the FDA regarding its insulin glargine biosimilar. Lannett sought and received comments from the FDA concerning the protocol and statistical analysis plan to be used in the pivotal clinical trial for the product. Lannett reported that it incorporated this feedback…