Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan
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DOI: 10.1080/14712598.2024.2377300
Abstract: ABSTRACT Background The ‘Questions and Answers (Q&A)’ document regarding Japanese biosimilar guideline elucidated that Japanese participant enrollment in at least one comparative clinical study was required for the marketing authorization application (MAA) of biosimilars in… read more here.
Keywords: comparative clinical; clinical study; biosimilar; requirement japanese ... See more keywords
Close, but no cigar: Biosimilar products and firm regulatory stance
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DOI: 10.1080/20479700.2020.1736790
Abstract: ABSTRACT The medical and pharmaceutical industries must commit to full consensus on biosimilar products. Regulatory recommendations and current resources applied to biosimilars should not be squandered. Additionally, continued lessons learned should be applied for the… read more here.
Keywords: biosimilar; firm regulatory; cigar biosimilar; products firm ... See more keywords