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A biosimilar marketing application should be submitted under the 351(k) section of the Public Health Service (PHS) act. To prove biosimilarity, such an application must include information about analytical studies, animal data, and clinical studies. According to section 351(k) of the PHS act, analytical testings should "demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components." Understandably, analytical testings should be a crucial first step in a biosimilar development program.


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