The Big Molecule Watch is monitoring clinical trial activities involving infliximab. Here we report on recent studies with Celltrion’s INFLECTRA (infliximab-dyyb). Earlier this year, clinical trial data was published from an observational real-world study of patients with inflammatory bowel disease, including Crohn’s disease (“CD”) and ulcerative colitis (“UC”) in the…
The Big Molecule Watch is monitoring Phase III clinical trials involving denosumab biosimilars. Here we report on the results of two recently completed studies. On June 30, 2022, a study was published showing that the efficacy of AryoGen Pharmed’s biosimilar denosumab candidate, ARYLIA, is noninferior to Amgen’s PROLIA for the…
As reported by Pulse and DailyPharm Korea, Celltrion recently filed an Investigational New Drug (IND) application with the FDA for a global Phase 3 clinical trial aimed at demonstrating its biosimilar’s (YUFLYMA) interchangeability with HUMIRA (adalimumab). The trial will evaluate the pharmacokinetics, efficacy, and safety of YUFLYMA in 366 patients with plaque psoriasis….
On August 2, 2022, Coherus BioSciences, Inc. announced that the FDA approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar interchangeable with LUCENTIS® (ranibizumab injection) for all five indications, with 12 months of exclusivity. Retina indications for which CIMERL is interchangeable include Neovascular (wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion…
Regeneron filed a complaint yesterday against Mylan in the U.S. District Court for the Northern District of West Virginia, alleging infringement of twenty-four patents under the BPCIA based on Mylan’s submission of an aBLA for M710, a proposed biosimilar of EYLEA (aflibercept). Regeneron asserts that use of Mylan’s M710 infringes seven…
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 August 1, 2022, Fresenius Kabi announced that the FDA accepted for review its Biologics License Application (BLA) for MSB11456, a biosimilar candidate for ACTEMRA (tocilizumab). The BLA includes both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations. This is the first BLA accepted by FDA for a tocilizumab biosimilar. …
Goodwin is actively seeking Associate attorneys to join its Intellectual Property (“IP”) Litigation team on both the East and West coast. Goodwin is looking for highly qualified, motivated, and team-oriented junior and mid-level IP litigation associates who focus on technology, life sciences, or both. Associates may join any of Goodwin’s…
The Big Molecule Watch is monitoring pending legislation in Congress that relates to biosimilars and biologics. In this post, we check in on the status of two currently pending bills related to Citizen Petitions. The first is H.R. 2883, Stop Stalling Access to Affordable Medications, which aims to stop the…
Sandoz announced this week that the U.S. Food and Drug Administration (FDA) has accepted the first-ever biologics license application (BLA) for a proposed natalizumab biosimilar to Biogen’s TYSABRI®. The proposed natalizumab biosimilar is for treatment of adults with highly active relapsing-remitting multiple sclerosis (RRMS). The application is for an intravenous…