Tagged as: Samsung Bioepis

EMA Reviews Samsung Bioepis’ Lucentis Biosimilar For Eye Diseases

Today, Samsung Bioepis and Biogen announced that the EMA has accepted for review its Marketing Authorization for their proposed biosimilar product referencing eye disease product Lucentis (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness. Last year, we reported…

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Samsung Bioepis Announces Phase 3 Exploratory Analyses Results of AYBINTIO (Bevacizumab)

Samsung Bioepis announced positive results yesterday from its exploratory analyses of the Phase 3 study of its biosimilar product, AYBINTIO (bevacizumab).  The study compared AYBINTIO’s efficacy to reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).  According to Vice President and Team Lead of Medical…

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Global Biosimilars Approval and Launch Updates

Shanghai Henlius Biotech, Inc. announced on August 14, 2020 the approval of its trastuzumab biosimilar HLX02 by the National Medical Products Administration (NMPA).  This same product was approved by the European Commission on July 27th.  According to the press release, this is the the first China-developed mAb biosimilar to be…

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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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Samsung Bioepis Announces Four-Year Follow-Up Data for its Trastuzumab Biosimilar and 24-Week Interim Results from Phase 3 Trial of its Proposed Ranibizumab Biosimilar

Samsung Bioepis Co., Ltd. announced on Friday that the four-year follow-up data from a Phase 3 study for ONTRUZANT, a biosimilar of HERCEPTIN (trastuzumab), will be presented later this month at the ASCO20 Virtual Scientific Program.  The data are from an ongoing five-year follow-up study assessing the cardiac safety and…

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Samsung Bioepis and Merck Announce U.S. Launch of Trastuzumab Biosimilar

On Wednesday, Samsung Bioepis and Merck announced the U.S. launch of Ontruzant® (trastuzumab-dttb), a biosimilar to Herceptin® (trastuzumab).  Ontruzant® is indicated for the treatment of HER2-overexpressing breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, and is available in both 150 mg single-dose vials and 420 mg multiple-dose vials. …

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Merck Transfers Biosimilars and Other Products to Spinoff Company

Last week, Merck announced its intention to spin-off products from its Women’s Health, legacy brands, and biosimilars businesses into a new, yet-to-be-named, independent, publicly traded company.  According to Merck, “NewCo will pursue global leadership and focused, sustainable growth in Women’s Health led by the growing and patent-protected NEXPLANON (etonogestrel implant)…

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Biosimilar and Biologic Business Developments Update – Collaborations and Licensing Deals

Last week, Almirall signed an agreement with WuXi Biologics to collaborate on multiple bispecific antibodies targeting dermatology conditions, including atopic dermatitis. Almirall’s press release indicated that, “[u]nder the terms of the agreement, Almirall has access to WuXi Biologics’ proprietary antibody platforms including WuXiBody™ to discover multiple novel bispecific antibodies.” This…

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Immunex and Samsung Bioepis Seek to Stay Etanercept Biosimilar Litigation (UPDATED)

This week, in the Immunex v. Samsung Bioepis BPCIA litigation regarding ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL, the New Jersey district court entered a Consent Injunction Order that prohibits Samsung Bioepis from using, importing, offering to sell, or selling any etanercept product in the United States, except as allowed…

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FDA Approves Samsung Bioepis's HADLIMA (adalimumab-bwwd)

Earlier this week, the U.S. FDA approved Samsung Bioepis’s  HADLIMA (adalimumab-bwwd), a biosimilar referencing HUMIRA, for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. HADLIMA is the fourth adalimumab biosimilar to receive approval in the U.S. According to…

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