Tagged as: biosimilars

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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Samsung Bioepis’s Etanercept Biosimilar Said to be Less Immunogenic than Enbrel

A research letter published by the British Journal of Dermatology from investigators in Samsung Bioepis’s biosimilar etanercept (SB4) clinical trials reports that, in addition to therapeutic equivalence between SB4 and reference etanercept (Enbrel), SB4 has been found to be less immunogenic than reference etanercept.  The letter notes that injection site…

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France Aims for 80% Biosimilar Penetration by 2022

In its 2018-2022 National Health Strategy, France aims for 80% biosimilar penetration by 2022, an increase from last year’s 70% target.  France’s support for biosimilars is not new.  Its 2014 budget pushed for pharmacy-level substitutions, and in 2017 the substitution policy was revamped and a biosimilar registry was created.  Although…

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