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BioCentury on BioBusiness
Feature Story

China gears up for biosimilars

China manufacturing requirements pose hurdle for global biosimilars players

By Tamra Sami, Senior Editor

Multinational biosimilars companies that lack manufacturing facilities in China could find themselves at a disadvantage to local rivals in getting biosimilars approved.

China FDA clarified in a recently released guideline that while biosimilars will be reviewed according to different technical criteria, they are subject to the same new drug approval pathway as innovative biologics.

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  • THE DISTILLERY brings you this week's most essential scientific findings in therapeutics, distilled by Innovations editors from a weekly review of more than 400 papers in 41 of the highest-impact journals in the fields of biotechnology, the life sciences and chemistry. The Distillery goes beyond the abstracts to explain the commercial relevance of featured research, including licensing status and companies working in the field, where applicable.

    This week in therapeutics includes important research findings on targets and compounds, grouped first by disease class and then alphabetically by indication.

    This week in techniques includes findings about research tools, disease models and manufacturing processes that have the potential to enable or improve all stages of drug discovery and development.

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