Tagged as: FDA

FDA Accepts Application From Samsung Bioepis and Biogen For Lucentis® (ranibizumab) Biosimilar

Samsung Bioepis and Biogen issued a press release on November 18 announcing that the U.S. Food and Drug Administration has accepted for review their Biologics License Application for SB11, a proposed biosimilar of Lucentis® (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) therapy used to treat retinal vascular disorders,…

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Genentech Sues Centus Over Proposed Bevacizumab Biosimilar

Yesterday, Genentech, Inc. filed a complaint in the Eastern District of Texas alleging that Centus Biotherapeutics, Ltd., Fujifilm Kyowa Kirin Biologics Co., Ltd., Fujifilm Corp., and Kyowa Kirin Co, Ltd. (collectively, Centus) proposed biosimilar to Genentech’s AVASTIN (bevacizumab) product infringes 10 U.S. patents.  Genentech’s complaint, styled as a Complaint for…

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SomaLogic Announces Agreement with FDA to Identify Biomarkers for Therapeutic Biologics

Yesterday, SomaLogic, Inc. announced a new five-year agreement and collaboration with the FDA’s Division of Applied Regulatory Science to evaluate the utility of large-scale analysis of proteins for the identification of biomarkers that may be used to help demonstrate whether a proposed biosimilar is biosimilar to a reference product.  According…

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FDA Deferring Action on Spectrum’s ROLONTIS Application As A Result of COVID-19 Related Travel Restrictions

On Monday, Spectrum Pharmaceuticals announced that the FDA was reportedly unable to conduct its required inspections of Spectrum’s Hanmi Bioplant due to travel restrictions related to the COVID-19 pandemic, and that as a result, the FDA was deferring action on the company’s Biologics License Application for ROLONTIS (eflapegrastim) until the…

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Equillium Announces Interim Data Results for Patients Treated with Itolizumab in Acute GVHD Study; Plans to Study Itolizumab in Patients with Severe COVID-19

BioSimilars Patent Dance

On August 10, 2020, Equillium, Inc. announced its interim data for its study of itolizumab as a first-line treatment in patients with acute graft-versus-host disease (GVHD).  GVHD is a multisystem disorder that is a common complication of allogeneic hematopoietic stem cell transplants, and is the leading cause of non-relapse mortality…

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Alvotech and Teva Announce Strategic Partnership to Collaborate in the U.S. Biosimilar Market

Today Alvotech and Teva announced that they have entered into an exclusive strategic partnership for the commercialization of five biosimilar candidates in the U.S.  Under the partnership agreement, Alvotech will be responsible for the development, registration and supply of the biosimilars, and Teva will be exclusively commercializing the products in…

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EYLEA (Aflibercept) Biosimilar Development Updates (Part 2)

Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011 and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). As previously reported, Momenta in collaboration with Mylan began…

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Biologic and Biosimilar Approval Updates

The U.S. FDA recently approved Genentech’s Phesgo™ for the treatment of early and metastatic HER2-positive breast cancer, in combination with chemotherapy.  Phesgo™ is a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase, administered via subcutaneous injection. Fujifilm Kyowa Kirin Biologics recently announced that it received approval in Japan for its adalimumab…

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