ARTICLE | Regulation
China gears up for biosimilars
China manufacturing requirements pose hurdle for global biosimilars players
March 30, 2015 7:00 AM UTC
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...