Instead of an NDA, new biologic drugs are approved using a Biologics License Application (BLA).

因此，与新药申请书不同，新的生物制品药物需填写生物制品许可申请(BLA)。

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Consequently, they have expressed their intention to submit a new Biologics License Application (BLA) to obtain marketing approval, rather than an abbreviated submission via the biosimilars pathway.

FORBES: Do You Think 'Biosimilars' Will Reduce Healthcare Expenditures? Think again.

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has determined that additional time is required to complete the review of the biologics license application (BLA) for ipilimumab in pre-treated advanced melanoma, and has moved its decision date from December 25, 2010 to March 26, 2011.

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