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Biologic drug products are therapeutic moieties that are manufactured using a
living system or organism. These are important life-saving drug products for
patients with unmet medical needs. They also comprise a growing segment
in the pharmaceutical industry. In 2007, worldwide sales of biological products
reached $94 billion US dollars, accounting for about 15.56% of the pharmaceuti
cal industry’s gross revenue. Meanwhile, many biological products face losing
their patents in the next decade. Attempts have been made therefore to establish
an abbreviated regulatory pathway for approval of biosimilar drug products, i.e.,
follow-on (or subsequently entered) biologics of the innovator’s biologic prod-
ucts, in order to reduce cost. However, due to the complexity of the structures
of biosimilar products and the nature of the manufacturing process, biological
products differ from the traditional small-molecule (chemical) drug products.
Although the concepts and principles for bioequivalence and interchangeability
could be the same for both chemical generics and biosimilar products, scien
tific challenges remain for establishing an abbreviated regulatory pathway for
approval of biosimilar products due to their unique characteristics.
This is intended to be the first book entirely devoted to the design and
analysis of analytical similarity assessment, including tests for similarity in
critical quality attributes at various stages of the biosimilar product develop
ment manufacturing process. It covers all of the statistical issues that may
occur at various stages of biosimilar product research and development.
The goal of this book to provide a useful desk reference and a state-of-the
art examination of this subject area to (i) scientists and researchers engaged
in pharmaceutical/clinical research and development of biologic products,
(ii) those in government regulatory agencies who have to make decisions on
the review and approval process of biological regulatory submissions, and
(iii) biostatisticians who provide the statistical support to the assessment of
analytical similarity of biosimilar products. It is my hope that this book can
serve as a bridge between the pharmaceutical/biotechnology industry, gov
ernment regulatory agencies, and academia
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