On October 26, 2023, Genentech, a member of the Roche Group, announced that the FDA approved VABYSMO (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO). RVO is the third indication approved for VABYSMO, in addition to wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular…
On May 26, 2023, the European Commission granted the marketing authorization to Samsung Bioepis for EPYSQLI, a biosimilar referencing SOLIRIS (eculizumab) developed by Alexion for the treatment of the paroxysmal nocturnal hemoglobinuria (PNH) that had global sales of approximately $5 trillion last year. As the first hematology biosimilar developed by…
On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia. The inspections took place between August 11 and August 30, 2022. The inspections were triggered by three preapproval inspections…
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 April 13, 2022, Amneal Pharmaceuticals, Inc. announced that the FDA approved its BLA for bevacizumab-maly, a biosimilar of Roche’s AVASTIN. The product will be marketed under the proprietary name ALYMSYS and represents the third bevacizumab biosimilar approved in the U.S, following Pfizer’s ZIRABEV (bevacizumab-bvzr) in 2019 and Amgen’s MVASI…
On January 28, 2022, the Food and Drug Administration (FDA) approved Genentech’s VABYSMO (faricimab-svoa) for the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). According to the Genentech press release, VABYSMO targets and neutralizes angiopoietin-2 (ang-2) and vascular endothelial growth factor-A (VEGF-A). The press release also…
On October 22, 2021 Roche announced the FDA’s approval of its ranibizumab intravitreal injection, marketed as Susvimo. Susvimo is a refillable ocular implant—requiring refills every six months—that continuously delivers medicine into the eye for the treatment of neovascular or wet age-related macular degeneration, a condition that can cause rapid and…
Roche has provided an update on its phase III study program comprising four Phase 3 trials evaluating the investigational medicine etrolizumab in people with moderately to severely active ulcerative colitis. These trials are titled HIBISCUS I, HIBISCUS II, HICKORY, and . Roche has reported that in the HIBISCUS I induction…
On March 30, 2020, Russian pharmaceutical company, Biocad, announced that it and its partner, ICM d.o.o., recently obtained European registration certification in Bosnia and Herzegovina for two cancer treatment biosimilars: Acellbia (rituximab), a biosimilar of Roche’s MabThera®, and Herticad (trastuzumab), a biosimilar of Roche’s Herceptin®. According to Biocad, the registration…
On January 15, 2020, the Romanian Competition Council fined fined Roche Romania SRL €12.9 million ($14.2 million) following two investigations into what the Competition Counsel found to be Roche’s anti-competitive practices related to its cancer drugs. In the first investigation, the Competition Council found that between 2017 and 2019 Roche…