process for the review of biosimilar biological product applications
(13) The term “process for the review of biosimilar biological product applications” means the following activities of the Secretary with respect to the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements: (A) The activities necessary for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements. (B) Actions related to submissions in connection with biosimilar biological product development, the issuance of action letters which approve biosimilar biological product applications or which set forth in detail the specific deficiencies in such applications, and where appropriate, the actions necessary to place such applications in condition for approval. (C) The inspection of biosimilar biological product establishments and other facilities undertaken as part of the Secretary’s review of pending biosimilar biological product applications and supplements. (D) Activities necessary for the release of lots of biosimilar biological products under section 262(k) of title 42 . (E) Monitoring of research conducted in connection with the review of biosimilar biological product applications. (F) Postmarket safety activities with respect to biologics approved under biosimilar biological product applications or supplements, including the following activities: (i) Collecting, developing, and reviewing safety information on biosimilar biological products, including adverse-event reports. (ii) Developing and using improved adverse-event data-collection systems, including information technology systems. (iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases. (iv) Implementing and enforcing section 355(o) of this title (relating to postapproval studies and clinical trials and labeling changes) and section 355(p) of this title (relating to risk evaluation and mitigation strategies). (v) Carrying out section 355(k)(5) of this title (relating to adverse-event reports and postmarket safety activities).