Tagged as: biosimilars

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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Update on Biosimilar Testing: Cinfa, Mylan/Biocon, Sandoz

Below is a roundup of several recently published comparative studies between biosimilars and reference biologics. In a study presented at the American Society of Hematology’s 59th Annual meeting, the authors concluded that there were no clinically meaningful differences in the safety profile of Cinfa Biotech’s B12019 biosimilar to Neulasta® (pegfilgrastim) compared with…

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FDA Publishes Best Practices for Communication Between IND Sponsors and FDA During Drug Development

Last week FDA issued new guidance for industry and FDA review staff, entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.”  The guidance is intended to “describe best practices and procedures for timely, transparent, and effective communications between [IND] sponsors and FDA at critical junctures in…

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