Tagged as: biosimilars

Trastuzumab Biosimilar Demonstrates Equivalence

The Journal of Clinical Oncology reported that Merck and Samsung Bioepis’ biosimilar to trastuzumab (Herceptin®), SB3, demonstrated equivalence to trastuzumab in recent Phase III trials. According to the report, in a phase III, randomized, double-blind study of 800 women with HER2-positive breast cancer, SB3 induced a rate of breast pathologic complete…

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Recommendatoins For The Use Of Biosimilars To Treat Rheumatological Diseases

The February edition of the Annals of the Rheumatic Diseases published a Recommendation titled, “Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases.” A panel of rheumatologists, dermatologists, gastroenterologists, and pharmacologists, as well as patients and regulators, were assembled to conduct a study aimed at developing recommendations regarding…

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Sandoz announces collaboration with Biocon on next-generation biosimilars

Last week, Sandoz announced a new collaboration with Asian biopharmaceutical company Biocon to “to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of…

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Brazilian Society of Clinical Oncology Publishes Position Statement on Biosimilars in Oncology

This month the Brazilian Society of Clinical Oncology (SBOC) published a position paper on approval and use issues concerning biosimilars in oncology. The paper, published in the Brazilian Journal of Medical and Biological Research, discusses “aspects related to definition, labeling/nomenclature, extrapolation, interchangeability, switching, automatic substitution, clinical standards on safety and…

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Alteogen reports similarity between its biosimilar ALT-L9 and Eylea®

South Korea’s Alteogen announced that its aflibercept biosimilar ALT-L9 had demonstrated similarity to the originator with no significant side effects in Michigan-based non-clinical trials. Aflibercept, known commercially as Eylea®, is sold by Regeneron for the treatment of wet age-related macular degeneration, which is the leading cause of blindness among the elderly….

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