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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 pharmaceutical 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 products, 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, scientific challenges remain for establishing an abbreviated regulatory pathway for approval of biosimilar products due to their unique characteristics.

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