On December 11, 2018, FDA issued its fifth final guidance document related to the development of biosimilars and interchangeability products entitled Questions and Answers on Biosimilar Development and the BPCI Act, as well as its fourth draft guidance document on the same topic, entitled New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).
Both documents provide answers to common questions from prospective applicants and other parties regarding BPCIA. They are intended to enhance transparency and facilitate development and approval of proposed biosimilars and interchangeable biosimilars, as well as describe FDA's interpretation of certain statutory requirements added by BPCIA.
The final and draft guidance documents dedicate their largest sections to questions and answers related to biosimilarity or interchangeability. Generally, they cover (1) sponsor contact with FDA to discuss its proposed development program, (2) biosimilar product characteristics and requirements, and (3) questions and answers on requirements for obtaining licensure. The concluding two sections in each document relate to requirements to submit a BLA for a "biological product," which covers "product class" definition and submission of a marketing application for a proposed antibody-drug conjugate, and exclusivity, which provides answers to questions regarding reference product exclusivity and unexpired orphan exclusivity.
Readers are encouraged to read the final guidance, also available on FDA's website.
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